Diazepam
DIAZEPAM Injection, USP
Approved
Approval ID
d1b5762f-307c-4c99-977d-d91d7dd22141
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-889
Application NumberANDA071583
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 17, 2007
FDA Product Classification
INGREDIENTS (5)
Propylene GlycolInactive
Quantity: 414.4 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Quantity: 50 mg in 1 mL
Code: OJ245FE5EU
Classification: IACT
DiazepamActive
Quantity: 5 mg in 1 mL
Code: Q3JTX2Q7TU
Classification: ACTIB
Benzyl AlcoholInactive
Quantity: 15 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
AlcoholInactive
Quantity: 81 mg in 1 mL
Code: 3K9958V90M
Classification: IACT