Home NDC 0115-1701 Albendazole
Product NDC 0115-1701
11-digit product format 001151701
Labeler code 0115
Product ID 0115-1701_2da2a777-2835-429d-b73a-31b8e0bde571
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name albendazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application NDA020666
Marketing category NDA
Marketing start 1996-06-11
Substance ALBENDAZOLE
Active strength 200 mg/1
Pharmacologic classes Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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date N020666-001 ALBENZA ALBENDAZOLE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11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UTC 2026-02 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020666-001 ALBENZA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020666-001 ALBENZA 200MG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# Additional Listing Data#
Finished product Yes
Brand name base Albendazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALBENDAZOLE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F4216019LN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199672 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-1701-49 Albendazole 2 in 1 BOTTLE TABLET, FILM COATED 2 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1701 ALBENDAZOLE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 9 Current NDC, Legacy NDC, 1 package rows 20240102_06b5eefc-0b95-4862-b9b6-770063f2adf0.zip
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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0115-1701-49 00115170149 2 TABLET, FILM COATED in 1 BOTTLE (0115-1701-49) 1996-06-11 0000-00-00 No No Current