diazepam

Generic: diazepam

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler asclemed usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diazepam 5 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-315
Product ID 76420-315_42708657-5977-a009-e063-6294a90a3919
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217843
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-12-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420315
Hyphenated Format 76420-315

Supplemental Identifiers

RxCUI
197589 197590 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 ANDA217843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (76420-315-00)
  • 100 TABLET in 1 BOTTLE (76420-315-01)
  • 500 TABLET in 1 BOTTLE (76420-315-05)
  • 10 TABLET in 1 BOTTLE (76420-315-10)
  • 20 TABLET in 1 BOTTLE (76420-315-20)
  • 30 TABLET in 1 BOTTLE (76420-315-30)
  • 60 TABLET in 1 BOTTLE (76420-315-60)
  • 90 TABLET in 1 BOTTLE (76420-315-90)
source: ndc

Packages (8)

76420-315-00 1000 TABLET in 1 BOTTLE (76420-315-00) 76420-315-01 100 TABLET in 1 BOTTLE (76420-315-01) 76420-315-05 500 TABLET in 1 BOTTLE (76420-315-05) 76420-315-10 10 TABLET in 1 BOTTLE (76420-315-10) 76420-315-20 20 TABLET in 1 BOTTLE (76420-315-20) 76420-315-30 30 TABLET in 1 BOTTLE (76420-315-30) 76420-315-60 60 TABLET in 1 BOTTLE (76420-315-60) 76420-315-90 90 TABLET in 1 BOTTLE (76420-315-90)

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": "42708657-5977-a009-e063-6294a90a3919", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589", "197590", "197591"], "spl_set_id": ["426f3da1-4105-ba0a-e063-6294a90a7a86"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (76420-315-00)", "package_ndc": "76420-315-00", "marketing_start_date": "20251031"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-315-01)", "package_ndc": "76420-315-01", "marketing_start_date": "20251031"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-315-05)", "package_ndc": "76420-315-05", "marketing_start_date": "20251031"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (76420-315-10)", "package_ndc": "76420-315-10", "marketing_start_date": "20251031"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (76420-315-20)", "package_ndc": "76420-315-20", "marketing_start_date": "20251031"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-315-30)", "package_ndc": "76420-315-30", "marketing_start_date": "20251031"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-315-60)", "package_ndc": "76420-315-60", "marketing_start_date": "20251031"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-315-90)", "package_ndc": "76420-315-90", "marketing_start_date": "20251031"}], "brand_name": "DIAZEPAM", "product_id": "76420-315_42708657-5977-a009-e063-6294a90a3919", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "76420-315", "dea_schedule": "CIV", "generic_name": "DIAZEPAM", "labeler_name": "ASCLEMED USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIAZEPAM", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/1"}], "application_number": "ANDA217843", "marketing_category": "ANDA", "marketing_start_date": "20231214", "listing_expiration_date": "20261231"}