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 INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diazepam 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6244
Product ID 0641-6244_273ae796-6561-4aaf-a38b-ea61be408347
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070313
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-05-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416244
Hyphenated Format 0641-6244

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (0641-6244-10) / 2 mL in 1 SYRINGE
source: ndc

Packages (1)

0641-6244-10 10 SYRINGE in 1 CARTON (0641-6244-10) / 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": "273ae796-6561-4aaf-a38b-ea61be408347", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["2120550"], "spl_set_id": ["2719720b-4918-4f08-b1de-b267f404505f"], "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": "10 SYRINGE in 1 CARTON (0641-6244-10)  / 2 mL in 1 SYRINGE", "package_ndc": "0641-6244-10", "marketing_start_date": "20210518"}], "brand_name": "Diazepam", "product_id": "0641-6244_273ae796-6561-4aaf-a38b-ea61be408347", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0641-6244", "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/mL"}], "application_number": "ANDA070313", "marketing_category": "ANDA", "marketing_start_date": "20210518", "listing_expiration_date": "20261231"}