Label: VERAPAMIL HYDROCHLORIDE injection, solution
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NDC Code(s):
70771-1601-1,
70771-1601-5,
70771-1601-7,
70771-1602-1, view more70771-1602-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated November 5, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Verapamil Hydrochloride Injection, USP
5 mg/2 mL
(2.5 mg/mL)
For Intravenous Use Only
Protect from light.
2 mL Single-Dose Vial
Rx only
Verapamil Hydrochloride Injection, USP
5 mg/2 mL
(2.5 mg/mL)
For Intravenous Use Only
Protect from light.
5 X 2 mL Single-Dose Vials
Rx only
Verapamil Hydrochloride Injection, USP
5 mg/2 mL
(2.5 mg/mL)
For Intravenous Use Only
Protect from light.
25 X 2 mL Single-Dose Vials
Rx only
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1601 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29) VERAPAMIL HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 8.5 mg in 1 mL WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1601-7 25 in 1 CARTON 10/22/2020 1 NDC:70771-1601-5 5 in 1 CARTON 1 NDC:70771-1601-1 2 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214215 10/22/2020 VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1602 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29) VERAPAMIL HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 8.5 mg in 1 mL WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1602-5 5 in 1 CARTON 10/22/2020 1 NDC:70771-1602-1 4 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214215 10/22/2020 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1601, 70771-1602) , ANALYSIS(70771-1601, 70771-1602)
