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Verapamil hydrochloride

Verapamil Hydrochloride Injection, USP Protect from light.  Rx only

Approved
Approval ID

eb3c66f6-581f-422b-9ca2-9b877b323a33

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 19, 2020

Manufacturers
FDA

Gland Pharma Limited

DUNS: 918601238

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

NDC Product Code68083-447
Application NumberANDA214361
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 19, 2020
Generic NameVerapamil hydrochloride

INGREDIENTS (5)

VERAPAMIL HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: V3888OEY5R
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Verapamil hydrochloride

PRODUCT DETAILS

NDC Product Code68083-448
Application NumberANDA214361
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 19, 2020
Generic NameVerapamil hydrochloride

INGREDIENTS (5)

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
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Verapamil hydrochloride - FDA Drug Approval Details