DEMEROL (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 100 mg/mL Syringe Cello Pack

NDC 0409-1377-01
Demerol™
CII
meperidine hydrochloride
injection, USP

100 mg / mL

For Intramuscular, Subcutaneous, or Intravenous Use

10 NexJect™ 1 mL Single-dose syringes with luer lock
Rx only
Needle not included

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Sterile Aqueous Injection

pH adjusted with NaOH or HCl.
For usual dosage and route of administration, see package insert.
Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.

PAA148384
Hospira, Inc.
Lake Forest, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 100 mg/mL Syringe Cello Pack
(click image for full-size original)
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1181
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
METACRESOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1181-30 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0409-1181-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 02/24/2006
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1176
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1176-30 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0409-1176-03)
1 NDC:0409-1176-03 1 mL in 1 CARTRIDGE This package is contained within the CARTON (0409-1176-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 08/25/2005
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1178
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1178-30 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0409-1178-03)
1 NDC:0409-1178-03 1 mL in 1 CARTRIDGE This package is contained within the CARTON (0409-1178-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 09/13/2005
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1179
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1179-30 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0409-1179-03)
1 NDC:0409-1179-03 1 mL in 1 CARTRIDGE This package is contained within the CARTON (0409-1179-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 10/12/2005
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1180
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1180-69 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0409-1180-59)
1 NDC:0409-1180-59 1 mL in 1 CARTRIDGE This package is contained within the CARTON (0409-1180-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 09/15/2005
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1362
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1362-01 10 SYRINGE in 1 CELLO PACK contains a SYRINGE (0409-1362-11)
1 NDC:0409-1362-11 1 mL in 1 SYRINGE This package is contained within the CELLO PACK (0409-1362-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1418
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1418-01 10 SYRINGE in 1 CELLO PACK contains a SYRINGE (0409-1418-11)
1 NDC:0409-1418-11 1 mL in 1 SYRINGE This package is contained within the CELLO PACK (0409-1418-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-2033
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-2033-01 10 SYRINGE in 1 CELLO PACK contains a SYRINGE (0409-2033-11)
1 NDC:0409-2033-11 1 mL in 1 SYRINGE This package is contained within the CELLO PACK (0409-2033-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021 04/16/2021
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1377
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1377-01 10 SYRINGE in 1 CELLO PACK contains a SYRINGE (0409-1377-11)
1 NDC:0409-1377-11 1 mL in 1 SYRINGE This package is contained within the CELLO PACK (0409-1377-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021 04/16/2021
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (0409-1176), ANALYSIS (0409-1178), ANALYSIS (0409-1179), ANALYSIS (0409-1180), ANALYSIS (0409-1181), ANALYSIS (0409-1362), ANALYSIS (0409-1377), ANALYSIS (0409-1418), ANALYSIS (0409-2033), MANUFACTURE (0409-1176), MANUFACTURE (0409-1178), MANUFACTURE (0409-1179), MANUFACTURE (0409-1180), MANUFACTURE (0409-1181), MANUFACTURE (0409-1362), MANUFACTURE (0409-1377), MANUFACTURE (0409-1418), MANUFACTURE (0409-2033), PACK (0409-1176), PACK (0409-1178), PACK (0409-1179), PACK (0409-1180), PACK (0409-1181), PACK (0409-1362), PACK (0409-1377), PACK (0409-1418), PACK (0409-2033), LABEL (0409-1176), LABEL (0409-1178), LABEL (0409-1179), LABEL (0409-1180), LABEL (0409-1181), LABEL (0409-1362), LABEL (0409-1377), LABEL (0409-1418), LABEL (0409-2033)

Revised: 11/2022 Hospira, Inc.

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