diazepam

Generic: diazepam

Labeler: sunrise pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler sunrise pharmaceutical, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diazepam 10 mg/1

Manufacturer
Sunrise Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11534-199
Product ID 11534-199_e95b8ea6-9d51-4621-bb87-a365121b08bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070464
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-12-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11534199
Hyphenated Format 11534-199

Supplemental Identifiers

RxCUI
197589 197590 197591
UNII
Q3JTX2Q7TU
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

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 ANDA070464 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (11534-199-01)
  • 1000 TABLET in 1 BOTTLE (11534-199-03)
  • 500 TABLET in 1 BOTTLE (11534-199-04)
source: ndc

Packages (3)

11534-199-01 100 TABLET in 1 BOTTLE (11534-199-01) 11534-199-03 1000 TABLET in 1 BOTTLE (11534-199-03) 11534-199-04 500 TABLET in 1 BOTTLE (11534-199-04)

Ingredients (1)

diazepam (10 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": "e95b8ea6-9d51-4621-bb87-a365121b08bb", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["197589", "197590", "197591"], "spl_set_id": ["34ac0b9d-d4ad-4aaa-8bee-902365f4e9a8"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Sunrise Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (11534-199-01)", "package_ndc": "11534-199-01", "marketing_start_date": "20241210"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (11534-199-03)", "package_ndc": "11534-199-03", "marketing_start_date": "20241210"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (11534-199-04)", "package_ndc": "11534-199-04", "marketing_start_date": "20241210"}], "brand_name": "DIAZEPAM", "product_id": "11534-199_e95b8ea6-9d51-4621-bb87-a365121b08bb", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "11534-199", "dea_schedule": "CIV", "generic_name": "diazepam", "labeler_name": "Sunrise Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIAZEPAM", "active_ingredients": [{"name": "DIAZEPAM", "strength": "10 mg/1"}], "application_number": "ANDA070464", "marketing_category": "ANDA", "marketing_start_date": "20241209", "listing_expiration_date": "20261231"}