diazepam

Generic: diazepam

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler lupin pharmaceuticals,inc.
Dosage Form GEL
Routes
RECTAL
Active Ingredients

diazepam 10 mg/2g

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-280
Product ID 43386-280_91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091076
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-10-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386280
Hyphenated Format 43386-280

Supplemental Identifiers

RxCUI
801961 801966
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 ANDA091076 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/2g
source: ndc
Packaging
  • 1 PACKAGE in 1 CARTON (43386-280-02) / 2 SYRINGE in 1 PACKAGE (43386-280-01) / 2 g in 1 SYRINGE (43386-280-03)
source: ndc

Packages (1)

43386-280-02 1 PACKAGE in 1 CARTON (43386-280-02) / 2 SYRINGE in 1 PACKAGE (43386-280-01) / 2 g in 1 SYRINGE (43386-280-03)

Ingredients (1)

diazepam (10 mg/2g)

Linked Drug Pages (1)

Diazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["801961", "801966"], "spl_set_id": ["d99b68aa-b3dc-49c8-8894-3da255cd26b0"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 PACKAGE in 1 CARTON (43386-280-02)  / 2 SYRINGE in 1 PACKAGE (43386-280-01)  / 2 g in 1 SYRINGE (43386-280-03)", "package_ndc": "43386-280-02", "marketing_start_date": "20231030"}], "brand_name": "Diazepam", "product_id": "43386-280_91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5", "dosage_form": "GEL", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43386-280", "dea_schedule": "CIV", "generic_name": "Diazepam", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "10 mg/2g"}], "application_number": "ANDA091076", "marketing_category": "ANDA", "marketing_start_date": "20231030", "listing_expiration_date": "20261231"}