Home NDC 52054-550 ALBENZA
Product NDC 52054-550
11-digit product format 520540550
Labeler code 52054
Product ID 52054-550_bbea4f30-6e15-48c4-89d8-e813757fea14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name albendazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amedra Pharmaceuticals LLC
Application NDA020666
Marketing category NDA
Marketing start 1996-06-11
Marketing end 2020-08-31
Substance ALBENDAZOLE
Active strength 200 mg/1
Pharmacologic classes Anthelmintic [EPC],Cytochrome P450 1A Inducers [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020666-001 ALBENZA ALBENDAZOLE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020666-001 ALBENZA 200MG TABLET / ORAL AB RLD, RS 1996-06-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020666-001 ALBENZA 200MG TABLET / ORAL RLD 1996-06-11 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALBENDAZOLE ACTIVE INGREDIENT F4216019LN ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 ALBENDAZOLE ACTIVE MOIETY F4216019LN ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 CROSPOVIDONE (19 MPA.S AT 5%) INACTIVE INGREDIENT 6B46OH7T95 ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 POLYVINYL ACETATE INACTIVE INGREDIENT 32K497ZK2U ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 SACCHARIN SODIUM MONOHYDRATE INACTIVE INGREDIENT A9CO00M9HV ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC] 8
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings#