diazepam

Generic: diazepam

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diazepam 5 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9769
Product ID 0404-9769_fac39e0b-2b18-42c7-b8fd-41dbddd999e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070313
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-11-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049769
Hyphenated Format 0404-9769

Supplemental Identifiers

RxCUI
2120550
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 ANDA070313 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 BAG (0404-9769-02) / 2 mL in 1 SYRINGE
source: ndc

Packages (1)

0404-9769-02 1 SYRINGE in 1 BAG (0404-9769-02) / 2 mL in 1 SYRINGE

Ingredients (1)

diazepam (5 mg/mL)

Linked Drug Pages (1)

DIAZEPAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "fac39e0b-2b18-42c7-b8fd-41dbddd999e8", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["2120550"], "spl_set_id": ["dcf7bc20-6c57-491a-b9e3-f42bacff8b99"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 BAG (0404-9769-02)  / 2 mL in 1 SYRINGE", "package_ndc": "0404-9769-02", "marketing_start_date": "20251118"}], "brand_name": "DIAZEPAM", "product_id": "0404-9769_fac39e0b-2b18-42c7-b8fd-41dbddd999e8", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0404-9769", "dea_schedule": "CIV", "generic_name": "diazepam", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIAZEPAM", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/mL"}], "application_number": "ANDA070313", "marketing_category": "ANDA", "marketing_start_date": "20251118", "listing_expiration_date": "20261231"}