Diazepam
diazePAM injection, USP
Approved
Approval ID
83646a0f-eb43-4871-b95e-683c2533d2be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Civica, Inc.
DUNS: 081373942
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIAZEPAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72572-140
Application NumberANDA210363
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIAZEPAM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (6)
DIAZEPAMActive
Quantity: 10 mg in 2 mL
Code: Q3JTX2Q7TU
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT