Bupivacaine Hydrochloride (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 250 mg/50 mL Vial Label — 1163

50 mL Multiple-dose Fliptop Vial

0.5% Bupivacaine
Hydrochloride Injection, USP
250 mg/50 mL (5 mg/mL)

For NERVE BLOCK.

Not for caudal, epidural or spinal anesthesia.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LOT ##-###-AA EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 250 mg/50 mL Vial Label -- 1163
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 250 mg/50 mL Vial Tray

50 mL Multiple-dose Fliptop Vial

Rx only
NDC 0409-1163-01
Contains 25 of NDC 0409-1163-18

0.5% Bupivacaine
Hydrochloride Injection, USP 250 mg/50 mL (5 mg/mL)

For NERVE BLOCK.

Not for caudal, epidural or spinal anesthesia.

Hospira

PRINCIPAL DISPLAY PANEL -- 250 mg/50 mL Vial Tray
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg/10 mL Vial Label

10 mL Single-dose Teartop Vial
Preservative-Free

0.75% Bupivacaine
Hydrochloride Injection, USP
75 mg/10 mL (7.5 mg/mL)

For EPIDURAL and RETROBULBAR ANESTHESIA.

Not for OBSTETRIC or SPINAL ANESTHESIA.

LOT ##-###-AA EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 75 mg/10 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg/10 mL Vial Tray

10 mL Single-dose Teartop Vial
Rx only
NDC 0409-1165-01
Contains 25 of NDC 0409-1165-18

Preservative-Free

0.75% Bupivacaine
Hydrochloride Injection, USP
75 mg/10 mL (7.5 mg/mL)

For EPIDURAL and
RETROBULBAR ANESTHESIA.

Not for OBSTETRIC or SPINAL ANESTHESIA.

Hospira

PRINCIPAL DISPLAY PANEL -- 75 mg/10 mL Vial Tray
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 225 mg/30 mL Vial Label

30 mL Single-dose Teartop Vial
Preservative-Free

0.75% Bupivacaine
Hydrochloride Injection, USP
225 mg/30 mL (7.5 mg/mL)

For EPIDURAL and RETROBULBAR ANESTHESIA.

Not for OBSTETRIC or SPINAL ANESTHESIA.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LOT ##-###-AA EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 225 mg/30 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 225 mg/30 mL Vial Tray

30 mL Single-dose Teartop Vial
Preservative-Free

0.75% Bupivacaine
Hydrochloride Injection, USP
225 mg/30 mL (7.5 mg/mL)

Rx only
NDC 0409-1165-02Contains 25 of NDC 0409-1165-19

For EPIDURAL and RETROBULBAR ANESTHESIA.

Not for OBSTETRIC or SPINAL ANESTHESIA.

Hospira

PRINCIPAL DISPLAY PANEL -- 225 mg/30 mL Vial Tray
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg/30 mL Vial Label — 9042

30 mL Single-dose Teartop Vial
Rx only

0.25% Bupivacaine HCl
75 mg/30 mL (2.5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine Hydrochloride
and Epinephrine Injection, USP

FOR INFILTRATION, NERVE BLOCK,
CAUDAL AND EPIDURAL ANESTHESIA.
Warning: Contains Sulfites

LOT ##-###-AA EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 75 mg/30 mL Vial Label -- 9042
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg/30 mL Vial Tray — 9042

30 mL Single-dose Teartop Vial

Rx only
NDC 0409-9042-17
Contains 25 of NDC 0409-9042-16

0.25% Bupivacaine Hydrochloride
75 mg/30 mL (2.5 mg/mL)

and epinephrine 1:200,000 Injection

Sterile, nonpyrogenic

Bupivacaine Hydrochloride and Epinephrine Injection, USP
FOR INFILTRATION, NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA.
Not for spinal anesthesia. Warning: Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL -- 75 mg/30 mL Vial Tray -- 9042
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg/30 mL Vial Label — 9045

30 mL Single-dose Teartop Vial
Discard unused portion

0.5% Bupivacaine HCl
150 mg/30 mL (5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine Hydrochloride and
Epinephrine Injection, USP

FOR NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA ONLY.

Warning: Contains Sulfites

PRINCIPAL DISPLAY PANEL -- 150 mg/30 mL Vial Label -- 9045
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg/30 mL Vial Tray — 9045

30 mL Single-dose Teartop Vial
Sterile, Nonpyrogenic

Rx only
NDC 0409-9045-17
Contains 25 of NDC 0409-9045-16

0.5% Bupivacaine Hydrochloride
150 mg/30 mL (5 mg/mL)

and epinephrine 1:200,000 Injection

Bupivacaine Hydrochloride and Epinephrine Injection, USP
FOR NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA ONLY.

Not for spinal anesthesia. Warning: Contains Sulfites

PRINCIPAL DISPLAY PANEL -- 150 mg/30 mL Vial Tray -- 9045
(click image for full-size original)
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1159
Route of Administration EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.6 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1159-01 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-1159-18)
1 NDC:0409-1159-18 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-1159-01)
2 NDC:0409-1159-02 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-1159-19)
2 NDC:0409-1159-19 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-1159-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070583 05/06/2005
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1160
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.6 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
METHYLPARABEN 1 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1160-01 25 VIAL, MULTI-DOSE in 1 TRAY contains a VIAL, MULTI-DOSE (0409-1160-18)
1 NDC:0409-1160-18 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the TRAY (0409-1160-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070590 04/30/2005
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1162
Route of Administration EPIDURAL, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1162-01 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-1162-18)
1 NDC:0409-1162-18 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-1162-01)
2 NDC:0409-1162-02 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-1162-19)
2 NDC:0409-1162-19 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-1162-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070584 11/22/2005
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1163
Route of Administration PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
METHYLPARABEN 1 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1163-01 25 VIAL, MULTI-DOSE in 1 TRAY contains a VIAL, MULTI-DOSE (0409-1163-18)
1 NDC:0409-1163-18 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the TRAY (0409-1163-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070597 03/31/2005
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1165
Route of Administration EPIDURAL, RETROBULBAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 7.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7.6 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1165-01 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-1165-18)
1 NDC:0409-1165-18 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-1165-01)
2 NDC:0409-1165-02 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-1165-19)
2 NDC:0409-1165-19 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-1165-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070585 06/08/2005
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride and epinephrine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9043
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
EPINEPHRINE BITARTRATE (EPINEPHRINE) EPINEPHRINE 5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.5 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
METHYLPARABEN 1 mg in 1 mL
SODIUM METABISULFITE 0.1 mg in 1 mL
EDETATE CALCIUM DISODIUM ANHYDROUS 0.1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9043-01 25 CARTON in 1 BOX contains a CARTON (0409-9043-11)
1 NDC:0409-9043-11 1 VIAL, MULTI-DOSE in 1 CARTON This package is contained within the BOX (0409-9043-01) and contains a VIAL, MULTI-DOSE
1 50 mL in 1 VIAL, MULTI-DOSE This package is contained within a CARTON (0409-9043-11) and a BOX (0409-9043-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071167 11/29/2005
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride and epinephrine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9046
Route of Administration PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
EPINEPHRINE BITARTRATE (EPINEPHRINE) EPINEPHRINE 5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.5 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM METABISULFITE 0.1 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
EDETATE CALCIUM DISODIUM ANHYDROUS 0.1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9046-01 25 CARTON in 1 BOX contains a CARTON (0409-9046-11)
1 NDC:0409-9046-11 1 VIAL, MULTI-DOSE in 1 CARTON This package is contained within the BOX (0409-9046-01) and contains a VIAL, MULTI-DOSE
1 50 mL in 1 VIAL, MULTI-DOSE This package is contained within a CARTON (0409-9046-11) and a BOX (0409-9046-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071170 07/26/2005
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride and epinephrine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9045
Route of Administration EPIDURAL, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
EPINEPHRINE BITARTRATE (EPINEPHRINE) EPINEPHRINE 5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.5 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM METABISULFITE 0.1 mg in 1 mL
EDETATE CALCIUM DISODIUM ANHYDROUS 0.1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9045-01 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0409-9045-11)
1 NDC:0409-9045-11 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0409-9045-01)
2 NDC:0409-9045-17 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-9045-16)
2 NDC:0409-9045-16 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-9045-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071168 05/18/2005
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride and epinephrine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9042
Route of Administration EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
EPINEPHRINE BITARTRATE (EPINEPHRINE) EPINEPHRINE 5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.5 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM METABISULFITE 0.1 mg in 1 mL
EDETATE CALCIUM DISODIUM ANHYDROUS 0.1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9042-01 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0409-9042-11)
1 NDC:0409-9042-11 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0409-9042-01)
2 NDC:0409-9042-17 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-9042-16)
2 NDC:0409-9042-16 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-9042-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071165 06/15/2005
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS (0409-1159), ANALYSIS (0409-1160), ANALYSIS (0409-1162), ANALYSIS (0409-1163), ANALYSIS (0409-1165), ANALYSIS (0409-9042), ANALYSIS (0409-9043), ANALYSIS (0409-9045), ANALYSIS (0409-9046), MANUFACTURE (0409-1159), MANUFACTURE (0409-1160), MANUFACTURE (0409-1162), MANUFACTURE (0409-1163), MANUFACTURE (0409-1165), MANUFACTURE (0409-9042), MANUFACTURE (0409-9043), MANUFACTURE (0409-9045), MANUFACTURE (0409-9046), PACK (0409-1159), PACK (0409-1160), PACK (0409-1162), PACK (0409-1163), PACK (0409-1165), PACK (0409-9042), PACK (0409-9043), PACK (0409-9045), PACK (0409-9046), LABEL (0409-1159), LABEL (0409-1160), LABEL (0409-1162), LABEL (0409-1163), LABEL (0409-1165), LABEL (0409-9042), LABEL (0409-9043), LABEL (0409-9045), LABEL (0409-9046)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 827731089 ANALYSIS (0409-1159), ANALYSIS (0409-1160), ANALYSIS (0409-1162), ANALYSIS (0409-1163), ANALYSIS (0409-1165), ANALYSIS (0409-9042), ANALYSIS (0409-9043), ANALYSIS (0409-9045), ANALYSIS (0409-9046)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (0409-9042), ANALYSIS (0409-9043), ANALYSIS (0409-9045), ANALYSIS (0409-9046)
Establishment
Name Address ID/FEI Operations
Pfizer Healthcare India Private Limited 860037912 ANALYSIS (0409-1159), ANALYSIS (0409-1160), ANALYSIS (0409-1162), ANALYSIS (0409-1163), ANALYSIS (0409-1165), MANUFACTURE (0409-1159), MANUFACTURE (0409-1160), MANUFACTURE (0409-1162), MANUFACTURE (0409-1163), MANUFACTURE (0409-1165), PACK (0409-1159), PACK (0409-1160), PACK (0409-1162), PACK (0409-1163), PACK (0409-1165), LABEL (0409-1159), LABEL (0409-1160), LABEL (0409-1162), LABEL (0409-1163), LABEL (0409-1165)

Revised: 01/2022 Hospira, Inc.

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