DILTIAZEM HYDROCHLORIDE
These highlights do not include all the information needed to use DILTIAZEM HYDROCHLORIDE IN DEXTROSE INJECTION safely and effectively. See full prescribing information for DILTIAZEM HYDROCHLORIDE IN DEXTROSE INJECTION.DILTIAZEM HYDROCHLORIDE IN DEXTROSE injection, for intravenous use onlyInitial U.S. Approval: 1982
Approved
Approval ID
51ddc49b-f2b5-4e79-93f5-e236fb546a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2021
Manufacturers
FDA
Exela Pharma Sciences,LLC
DUNS: 831274399
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diltiazem hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-3500
Application NumberNDA215252
Product Classification
M
Marketing Category
C73594
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 30, 2021
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
DILTIAZEM HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: OLH94387TE
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
diltiazem hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-3000
Application NumberNDA215252
Product Classification
M
Marketing Category
C73594
G
Generic Name
diltiazem hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 30, 2021
FDA Product Classification
INGREDIENTS (7)
DILTIAZEM HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: OLH94387TE
Classification: ACTIB
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT