Home NDC 42291-971 Zafirlukast
Product NDC 42291-971
11-digit product format 422910971
Labeler code 42291
Product ID 42291-971_3b3c7fd6-2d93-6df8-e063-6294a90a841f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zafirlukast
Dosage form TABLET, COATED
Route ORAL
Labeler AvKARE
Application NDA020547
Marketing category NDA
Marketing start 2023-04-05
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 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 N020547-001 ACCOLATE ZAFIRLUKAST 20MG TABLET / ORAL AB RLD, RS 1996-09-26 N020547-003 ACCOLATE ZAFIRLUKAST 10MG TABLET / ORAL AB RLD 1999-09-17
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.
Product history page 1 of 3 · 86 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 2026-09-14 22:38:34 2026-08 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020547-001 ACCOLATE 20MG TABLET / ORAL AB RLD, RS 1996-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020547-003 ACCOLATE 10MG TABLET / ORAL AB RLD 1999-09-17 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 42291-971-60 Zafirlukast 60 in 1 BOTTLE TABLET, COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-971 ZAFIRLUKAST TABLET, COATED [AVKARE] 2 Current NDC, 1 package rows 20230426_f89a821d-396f-a3aa-e053-6294a90a4577.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 Sample Exclude flag Status 42291-971-60 42291097160 60 TABLET, COATED in 1 BOTTLE (42291-971-60) 2023-04-05 No No Current