MedPath

Verapamil Hydrochloride

Verapamil Hydrochloride Injection, USP(5 mg/2 mL and 10 mg/4 mL)Rx only

Approved
Approval ID

9055ed6b-f466-4f38-a9d9-f22e9ac97ad4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 23, 2023

Manufacturers
FDA

Amneal Pharmaceuticals LLC

DUNS: 827748190

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Verapamil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70121-1585
Application NumberANDA210994
Product Classification
M
Marketing Category
C73584
G
Generic Name
Verapamil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
FDA Product Classification

INGREDIENTS (4)

VERAPAMIL HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: V3888OEY5R
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Verapamil Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70121-1586
Application NumberANDA210994
Product Classification
M
Marketing Category
C73584
G
Generic Name
Verapamil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
FDA Product Classification

INGREDIENTS (4)

VERAPAMIL HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: V3888OEY5R
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Verapamil Hydrochloride - FDA Drug Approval Details