diazepam

Generic: diazepam

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diazepam
Generic Name diazepam
Labeler zydus pharmaceuticals usa inc.
Dosage Form GEL
Routes
RECTAL
Active Ingredients

diazepam 2.5 mg/.5mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-2078
Product ID 70710-2078_587ad24b-6edd-4cd1-9995-3d12b42c0c0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217468
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707102078
Hyphenated Format 70710-2078

Supplemental Identifiers

RxCUI
801957 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 ANDA217468 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/.5mL
source: ndc
Packaging
  • 2 SYRINGE, PLASTIC in 1 PACKAGE (70710-2078-2) / .5 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

70710-2078-2 2 SYRINGE, PLASTIC in 1 PACKAGE (70710-2078-2) / .5 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

diazepam (2.5 mg/.5mL)

Linked Drug Pages (1)

Diazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "587ad24b-6edd-4cd1-9995-3d12b42c0c0e", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["Q3JTX2Q7TU"], "rxcui": ["801957", "801961", "801966"], "spl_set_id": ["652714c7-25c4-4d05-979d-8eee3b6f2f4d"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, PLASTIC in 1 PACKAGE (70710-2078-2)  / .5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "70710-2078-2", "marketing_start_date": "20251215"}], "brand_name": "Diazepam", "product_id": "70710-2078_587ad24b-6edd-4cd1-9995-3d12b42c0c0e", "dosage_form": "GEL", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "70710-2078", "dea_schedule": "CIV", "generic_name": "Diazepam", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diazepam", "active_ingredients": [{"name": "DIAZEPAM", "strength": "2.5 mg/.5mL"}], "application_number": "ANDA217468", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}