Home NDC 59651-292-59 Zafirlukast
Product NDC 59651-292
Requested package NDC 59651-292-59
11-digit product format 596510292
Labeler code 59651
Product ID 59651-292_8bdb47c5-9d19-4d59-94c8-62c117525e7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zafirlukast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA213163
Marketing category ANDA
Marketing start 2023-11-27
Substance ZAFIRLUKAST
Active strength 20 mg/1
Pharmacologic classes Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213163-001 ZAFIRLUKAST ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 A213163-002 ZAFIRLUKAST ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-09-14 22:38:34 2026-08 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213163-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2023-11-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213163-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2023-11-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Zafirlukast
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZAFIRLUKAST 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XZ629S5L50 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199655 Internal RxNorm lookup 313758 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 59651-292-60 Zafirlukast 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-292 ZAFIRLUKAST TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 Current NDC, 1 package rows 20231204_8bdb47c5-9d19-4d59-94c8-62c117525e7f.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 Status 59651-292-59 59651029259 5000 TABLET, FILM COATED in 1 BAG (59651-292-59) 27-NOV-23 Current