diazepam

Generic: diazepam

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

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler pharmaceutical associates, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diazepam 5 mg/5mL

Manufacturer
Pharmaceutical Associates, Inc.

Identifiers & Regulatory

Product NDC 0121-0905
Product ID 0121-0905_cc0d49f5-c681-9d48-e053-2a95a90a597b
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 01210905
Hyphenated Format 0121-0905

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (0121-0905-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0905-05)
source: ndc

Packages (1)

0121-0905-94 3 TRAY in 1 CASE (0121-0905-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0905-05)

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": "cc0d49f5-c681-9d48-e053-2a95a90a597b", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["309843"], "spl_set_id": ["b24f1eb7-3dab-4183-b81f-f86ac62aedd8"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Pharmaceutical Associates, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (0121-0905-94)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0905-05)", "package_ndc": "0121-0905-94", "marketing_start_date": "20210226"}], "brand_name": "Diazepam", "product_id": "0121-0905_cc0d49f5-c681-9d48-e053-2a95a90a597b", "dosage_form": "SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0121-0905", "dea_schedule": "CIV", "generic_name": "Diazepam", "labeler_name": "Pharmaceutical Associates, 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"}