albendazole

Generic: albendazole

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albendazole
Generic Name albendazole
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

albendazole 200 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-681
Product ID 46708-681_3b4945c7-56e9-47ed-a7ac-5078a1a50b85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215652
Listing Expiration 2026-12-31
Marketing Start 2024-09-11

Pharmacologic Class

Established (EPC)
anthelmintic [epc]
Mechanism of Action
cytochrome p450 1a inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708681
Hyphenated Format 46708-681

Supplemental Identifiers

RxCUI
199672
UNII
F4216019LN
NUI
N0000175481 N0000191624

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 albendazole (source: ndc)
Generic Name albendazole (source: ndc)
Application Number ANDA215652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE (46708-681-02)
  • 28 TABLET, FILM COATED in 1 BOTTLE (46708-681-28)
source: ndc

Packages (2)

46708-681-02 2 TABLET, FILM COATED in 1 BOTTLE (46708-681-02) 46708-681-28 28 TABLET, FILM COATED in 1 BOTTLE (46708-681-28)

Ingredients (1)

albendazole (200 mg/1)

Linked Drug Pages (1)

Albendazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b4945c7-56e9-47ed-a7ac-5078a1a50b85", "openfda": {"nui": ["N0000175481", "N0000191624"], "unii": ["F4216019LN"], "rxcui": ["199672"], "spl_set_id": ["3b4945c7-56e9-47ed-a7ac-5078a1a50b85"], "pharm_class_epc": ["Anthelmintic [EPC]"], "pharm_class_moa": ["Cytochrome P450 1A Inducers [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (46708-681-02)", "package_ndc": "46708-681-02", "marketing_start_date": "20240911"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (46708-681-28)", "package_ndc": "46708-681-28", "marketing_start_date": "20240911"}], "brand_name": "Albendazole", "product_id": "46708-681_3b4945c7-56e9-47ed-a7ac-5078a1a50b85", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anthelmintic [EPC]", "Cytochrome P450 1A Inducers [MoA]"], "product_ndc": "46708-681", "generic_name": "Albendazole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albendazole", "active_ingredients": [{"name": "ALBENDAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA215652", "marketing_category": "ANDA", "marketing_start_date": "20240911", "listing_expiration_date": "20261231"}