Diazepam
Diazepam Tablets USP C-IV
Approved
Approval ID
f84b28ff-aae1-4796-a8f0-e06e146235a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2020
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-427
Application NumberANDA071136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2020
FDA Product Classification
INGREDIENTS (5)
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
DiazepamActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT