DIAZEPAM
Diazepam Tablets, USP CIV Rx only
Approved
Approval ID
32c3af91-a57a-1278-e063-6294a90ae5ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2025
Manufacturers
FDA
Advanced Rx of Tennessee, LLC
DUNS: 117023142
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 Code80425-0511
Application NumberANDA217843
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2025
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIAZEPAMActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/14/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 4/14/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/14/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/14/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/14/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/14/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/14/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/14/2025
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 4/14/2025
DRUG ABUSE AND DEPENDENCE SECTION
LOINC: 42227-9Updated: 4/14/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/14/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/14/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/14/2025
SPL MEDGUIDE SECTION
LOINC: 42231-1Updated: 4/14/2025