Home NDC 49884-554 Zafirlukast
Product NDC 49884-554
11-digit product format 498840554
Labeler code 49884
Product ID 49884-554_8599c60a-49fc-47f3-b49c-2b089f79b202
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zafirlukast
Dosage form TABLET, COATED
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application NDA020547
Marketing category NDA
Marketing start 2010-11-19
Marketing end 2024-09-30
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49884-554-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49884-554-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49884-554-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49884-554-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49884-554-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49884-554-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49884-554-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49884-554-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49884-554-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49884-554-02 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49884-554-02 D Discontinued by firm 367a005e9d99…383a685ebd0f…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 49884-554-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…
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.
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49884-554-02 49884055402 60 TABLET, COATED in 1 BOTTLE (49884-554-02) 2010-11-19 0000-00-00 No No Current