albendazole

Generic: albendazole

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albendazole
Generic Name albendazole
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

albendazole 200 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2712
Product ID 0591-2712_071a50e4-8606-40a7-b09c-e7281ccac80b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208094
Listing Expiration 2026-12-31
Marketing Start 2019-06-13

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 05912712
Hyphenated Format 0591-2712

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 ANDA208094 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE (0591-2712-02)
source: ndc

Packages (1)

0591-2712-02 2 TABLET, FILM COATED in 1 BOTTLE (0591-2712-02)

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": "071a50e4-8606-40a7-b09c-e7281ccac80b", "openfda": {"nui": ["N0000175481", "N0000191624"], "unii": ["F4216019LN"], "rxcui": ["199672"], "spl_set_id": ["f5c7b8cb-a81f-4b13-b3c4-f6edaf880d3b"], "pharm_class_epc": ["Anthelmintic [EPC]"], "pharm_class_moa": ["Cytochrome P450 1A Inducers [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (0591-2712-02)", "package_ndc": "0591-2712-02", "marketing_start_date": "20190613"}], "brand_name": "Albendazole", "product_id": "0591-2712_071a50e4-8606-40a7-b09c-e7281ccac80b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anthelmintic [EPC]", "Cytochrome P450 1A Inducers [MoA]"], "product_ndc": "0591-2712", "generic_name": "Albendazole", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albendazole", "active_ingredients": [{"name": "ALBENDAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA208094", "marketing_category": "ANDA", "marketing_start_date": "20190613", "listing_expiration_date": "20261231"}