diazepam

Generic: diazepam

Labeler: natco pharma usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler natco pharma usa llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

diazepam 5 mg/mL

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-137
Product ID 69339-137_2a224626-a982-4a57-9ff6-8b4f69e0c4c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211998
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69339137
Hyphenated Format 69339-137

Supplemental Identifiers

RxCUI
309845
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 ANDA211998 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 VIAL, MULTI-DOSE in 1 CARTON (69339-137-05) / 10 mL in 1 VIAL, MULTI-DOSE (69339-137-01)
source: ndc

Packages (1)

69339-137-05 5 VIAL, MULTI-DOSE in 1 CARTON (69339-137-05) / 10 mL in 1 VIAL, MULTI-DOSE (69339-137-01)

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": "2a224626-a982-4a57-9ff6-8b4f69e0c4c0", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["309845"], "spl_set_id": ["19d0e3e5-f081-4574-9f0a-e7e97a88c7a9"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, MULTI-DOSE in 1 CARTON (69339-137-05)  / 10 mL in 1 VIAL, MULTI-DOSE (69339-137-01)", "package_ndc": "69339-137-05", "marketing_start_date": "20200701"}], "brand_name": "Diazepam", "product_id": "69339-137_2a224626-a982-4a57-9ff6-8b4f69e0c4c0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "69339-137", "dea_schedule": "CIV", "generic_name": "DIAZEPAM", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "5 mg/mL"}], "application_number": "ANDA211998", "marketing_category": "ANDA", "marketing_start_date": "20200701", "listing_expiration_date": "20261231"}