Home NDC 43598-452 Albendazole
Product NDC 43598-452
11-digit product format 435980452
Labeler code 43598
Product ID 43598-452_370b6498-30f2-48a4-f32a-9ee671cf294e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albendazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr.Reddys Laboratories Inc
Application ANDA211034
Marketing category ANDA
Marketing start 2021-01-26
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 A211034-001 ALBENDAZOLE ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211034-001 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.
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 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2021-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2021-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2021-01-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2021-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2021-01-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2021-01-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB 2021-01-26 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211034-001 ALBENDAZOLE 200MG TABLET / ORAL AB RS 2021-01-26 a50c72e98297…
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 43598-452-02 Albendazole 2 in 1 BOTTLE TABLET, FILM COATED 2 5 43598-452-17 Albendazole 8 in 1 BLISTER PACK TABLET, FILM COATED 8 5 43598-452-17 Albendazole 1 in 1 CARTON TABLET, FILM COATED 1 5 43598-452-63 Albendazole 28 in 1 BOTTLE TABLET, FILM COATED 28 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-452 ALBENDAZOLE TABLET, FILM COATED [DR.REDDYS LABORATORIES INC] 5 Current NDC, Legacy NDC, 4 package rows 20210129_9ac95554-94c9-1f38-8f49-ec11979e4ba4.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 Units Marketing start Marketing end Sample Exclude flag Status 43598-452-02 43598045202 2 TABLET, FILM COATED in 1 BOTTLE (43598-452-02) 2021-01-26 0000-00-00 No No Current 43598-452-17 43598045217 1 BLISTER PACK in 1 CARTON (43598-452-17) / 8 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2021-01-26 0000-00-00 No No Current 43598-452-63 43598045263 28 TABLET, FILM COATED in 1 BOTTLE (43598-452-63) 2021-01-26 0000-00-00 No No Current