diazepam

Generic: diazepam

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diazepam 5 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3682
Product ID 68071-3682_2a3162ec-9701-d87d-e063-6394a90adbd3
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 680713682
Hyphenated Format 68071-3682

Supplemental Identifiers

RxCUI
197591
UPC
0368071368260
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
  • 10 TABLET in 1 BOTTLE (68071-3682-1)
  • 6 TABLET in 1 BOTTLE (68071-3682-6)
source: ndc

Packages (2)

68071-3682-1 10 TABLET in 1 BOTTLE (68071-3682-1) 68071-3682-6 6 TABLET in 1 BOTTLE (68071-3682-6)

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": "2a3162ec-9701-d87d-e063-6394a90adbd3", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0368071368260"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197591"], "spl_set_id": ["21785bb2-cc96-7973-e063-6294a90ab1b8"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68071-3682-1)", "package_ndc": "68071-3682-1", "marketing_start_date": "20240906"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (68071-3682-6)", "package_ndc": "68071-3682-6", "marketing_start_date": "20240906"}], "brand_name": "DIAZEPAM", "product_id": "68071-3682_2a3162ec-9701-d87d-e063-6394a90adbd3", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "68071-3682", "dea_schedule": "CIV", "generic_name": "DIAZEPAM", "labeler_name": "NuCare Pharmaceuticals, 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"}