diazepam

Generic: diazepam

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diazepam 5 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0496
Product ID 80425-0496_32c41fa1-f6d5-fe36-e063-6394a90a23bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070325
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-02-02

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250496
Hyphenated Format 80425-0496

Supplemental Identifiers

RxCUI
197589 197591
UNII
Q3JTX2Q7TU
NUI
N0000175694 M0002356

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diazepam (source: ndc)
Generic Name diazepam (source: ndc)
Application Number ANDA070325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (80425-0496-1)
  • 60 TABLET in 1 BOTTLE, PLASTIC (80425-0496-2)
  • 90 TABLET in 1 BOTTLE, PLASTIC (80425-0496-3)
source: ndc

Packages (3)

80425-0496-1 30 TABLET in 1 BOTTLE, PLASTIC (80425-0496-1) 80425-0496-2 60 TABLET in 1 BOTTLE, PLASTIC (80425-0496-2) 80425-0496-3 90 TABLET in 1 BOTTLE, PLASTIC (80425-0496-3)

Ingredients (1)

diazepam (5 mg/1)

Linked Drug Pages (1)

Diazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32c41fa1-f6d5-fe36-e063-6394a90a23bb", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589", "197591"], "spl_set_id": ["2d322c6a-7f7e-1cc4-e063-6294a90a8e2e"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (80425-0496-1)", "package_ndc": "80425-0496-1", "marketing_start_date": "20250202"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (80425-0496-2)", "package_ndc": "80425-0496-2", "marketing_start_date": "20250202"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (80425-0496-3)", "package_ndc": "80425-0496-3", "marketing_start_date": "20250202"}], "brand_name": "Diazepam", "product_id": "80425-0496_32c41fa1-f6d5-fe36-e063-6394a90a23bb", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "80425-0496", "dea_schedule": "CIV", "generic_name": "diazepam", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/1"}], "application_number": "ANDA070325", "marketing_category": "ANDA", "marketing_start_date": "20250202", "listing_expiration_date": "20261231"}