diazepam

Generic: diazepam

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

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diazepam 5 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3188
Product ID 0054-3188_d1ff8e50-faf9-4475-9fa0-314a620f8869
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070928
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1987-04-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00543188
Hyphenated Format 0054-3188

Supplemental Identifiers

RxCUI
309843
UPC
0300543188631
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 ANDA070928 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE, PLASTIC (0054-3188-63)
source: ndc

Packages (1)

0054-3188-63 500 mL in 1 BOTTLE, PLASTIC (0054-3188-63)

Ingredients (1)

diazepam (5 mg/5mL)

Linked Drug Pages (1)

Diazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d1ff8e50-faf9-4475-9fa0-314a620f8869", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0300543188631"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["309843"], "spl_set_id": ["9e85abed-1a8b-4762-a31f-f2c7f196b8af"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE, PLASTIC (0054-3188-63)", "package_ndc": "0054-3188-63", "marketing_start_date": "19870403"}], "brand_name": "Diazepam", "product_id": "0054-3188_d1ff8e50-faf9-4475-9fa0-314a620f8869", "dosage_form": "SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0054-3188", "dea_schedule": "CIV", "generic_name": "Diazepam", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/5mL"}], "application_number": "ANDA070928", "marketing_category": "ANDA", "marketing_start_date": "19870403", "listing_expiration_date": "20261231"}