Active ingredient
Albendazole
10 finished FDA listings contain Albendazole as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ALBENDAZOLE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 10
- Strengths listed
- 200 mg/1
- Brand names in FDA listings
- Albenza
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 430
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020666 | IMPAX LABS INC | 1996-06-11 | 2 |
| ANDA 211117 | EDENBRIDGE PHARMS | 2019-05-14 | 2 |
| ANDA 208094 | ACTAVIS ELIZABETH | 2019-05-20 | 1 |
| ANDA 213435 | MSN | 2021-01-22 | 2 |
| ANDA 211034 | DR REDDYS | 2021-01-26 | 1 |
| ANDA 215652 | ALEMBIC | 2024-09-04 | 2 |
Official labeling on DailyMed
- ALBENDAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 5 · 2026-08-28
- ALBENDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] · version 43 · 2026-07-24
- ALBENZA (ALBENDAZOLE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] · version 14 · 2024-10-25
- ALBENDAZOLE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2024-09-19
- ALBENDAZOLE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] · version 2 · 2024-09-18
- ALBENDAZOLE TABLET [BRYANT RANCH PREPACK] · version 100 · 2024-07-02
- ALBENDAZOLE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 9 · 2024-01-02
- ALBENDAZOLE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] · version 12 · 2022-08-04
- ALBENDAZOLE TABLET [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2021-02-26
- ALBENDAZOLE TABLET, FILM COATED [DR.REDDYS LABORATORIES INC] · version 5 · 2021-01-29
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.