Home NDC 0591-2712 Albendazole
Product NDC 0591-2712
11-digit product format 005912712
Labeler code 0591
Product ID 0591-2712_071a50e4-8606-40a7-b09c-e7281ccac80b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albendazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA208094
Marketing category ANDA
Marketing start 2019-06-13
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-2712 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 0591-2712 0591-2712-00 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 0591-2712 0591-2712-77 UNFINISHED Active or certified unfinished drug listing 2026-08-03
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 · 51 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 A208094-001 ALBENDAZOLE ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208094-001 AB
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 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208094-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2019-05-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 0591-2712-02 Albendazole 2 in 1 BOTTLE TABLET, FILM COATED 2 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2712 ALBENDAZOLE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 12 Current NDC, Legacy NDC, 1 package rows 20220804_f5c7b8cb-a81f-4b13-b3c4-f6edaf880d3b.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 · 1 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 0591-2712-00 00591271200 15016 TABLET, FILM COATED in 1 BOX (0591-2712-00) 13-JUN-19 Current 0591-2712-02 00591271202 2 TABLET, FILM COATED in 1 BOTTLE (0591-2712-02) 2019-06-13 0000-00-00 No No Current 0591-2712-77 00591271277 18024 TABLET, FILM COATED in 1 CONTAINER (0591-2712-77) 22-AUG-24 Current