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 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 — 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 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 — 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 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 — 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 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 — 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 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

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.