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 10 mg/2mL

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-136
Product ID 69339-136_2188da13-b1b1-4190-98f6-dedf2489aeb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210363
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69339136
Hyphenated Format 69339-136

Supplemental Identifiers

RxCUI
2120550
UPC
0369339136935
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 ANDA210363 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/2mL
source: ndc
Packaging
  • 10 SYRINGE, GLASS in 1 CARTON (69339-136-97) / 2 mL in 1 SYRINGE, GLASS (69339-136-93)
source: ndc

Packages (1)

69339-136-97 10 SYRINGE, GLASS in 1 CARTON (69339-136-97) / 2 mL in 1 SYRINGE, GLASS (69339-136-93)

Ingredients (1)

diazepam (10 mg/2mL)

Linked Drug Pages (2)

Diazepam ndc-match (0.9) Diazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "2188da13-b1b1-4190-98f6-dedf2489aeb9", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0369339136935"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["2120550"], "spl_set_id": ["a14f5930-a3ac-4996-9778-df5baa3d0bab"], "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": "10 SYRINGE, GLASS in 1 CARTON (69339-136-97)  / 2 mL in 1 SYRINGE, GLASS (69339-136-93)", "package_ndc": "69339-136-97", "marketing_start_date": "20250501"}], "brand_name": "Diazepam", "product_id": "69339-136_2188da13-b1b1-4190-98f6-dedf2489aeb9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "69339-136", "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": "10 mg/2mL"}], "application_number": "ANDA210363", "marketing_category": "ANDA", "marketing_start_date": "20190322", "listing_expiration_date": "20261231"}