albendazole

Generic: albendazole

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albendazole
Generic Name albendazole
Labeler dr.reddys laboratories inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

albendazole 200 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-452
Product ID 43598-452_370b6498-30f2-48a4-f32a-9ee671cf294e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211034
Listing Expiration 2026-12-31
Marketing Start 2021-01-26

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 43598452
Hyphenated Format 43598-452

Supplemental Identifiers

RxCUI
199672
UPC
0343598452029
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 ANDA211034 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE (43598-452-02)
  • 1 BLISTER PACK in 1 CARTON (43598-452-17) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • 28 TABLET, FILM COATED in 1 BOTTLE (43598-452-63)
source: ndc

Packages (3)

43598-452-02 2 TABLET, FILM COATED in 1 BOTTLE (43598-452-02) 43598-452-17 1 BLISTER PACK in 1 CARTON (43598-452-17) / 8 TABLET, FILM COATED in 1 BLISTER PACK 43598-452-63 28 TABLET, FILM COATED in 1 BOTTLE (43598-452-63)

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": "370b6498-30f2-48a4-f32a-9ee671cf294e", "openfda": {"nui": ["N0000175481", "N0000191624"], "upc": ["0343598452029"], "unii": ["F4216019LN"], "rxcui": ["199672"], "spl_set_id": ["9ac95554-94c9-1f38-8f49-ec11979e4ba4"], "pharm_class_epc": ["Anthelmintic [EPC]"], "pharm_class_moa": ["Cytochrome P450 1A Inducers [MoA]"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (43598-452-02)", "package_ndc": "43598-452-02", "marketing_start_date": "20210126"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (43598-452-17)  / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "43598-452-17", "marketing_start_date": "20210126"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (43598-452-63)", "package_ndc": "43598-452-63", "marketing_start_date": "20210126"}], "brand_name": "Albendazole", "product_id": "43598-452_370b6498-30f2-48a4-f32a-9ee671cf294e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anthelmintic [EPC]", "Cytochrome P450 1A Inducers [MoA]"], "product_ndc": "43598-452", "generic_name": "Albendazole", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albendazole", "active_ingredients": [{"name": "ALBENDAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA211034", "marketing_category": "ANDA", "marketing_start_date": "20210126", "listing_expiration_date": "20261231"}