Home NDC 53808-0203 ACCOLATE
Product NDC 53808-0203
11-digit product format 538080203
Labeler code 53808
Product ID 53808-0203_9798152d-b3b5-4fc6-985e-10b59177464b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zafirlukast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application NDA020547
Marketing category NDA
Marketing start 2009-07-01
Marketing end 0000-00-00
Substance ZAFIRLUKAST
Active strength 20 mg/1
Pharmacologic classes Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0203-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0203-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0203-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0203-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0203-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0203-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0203-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0203-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0203-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0203-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0203-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0203-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0203-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0203-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0203-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0203-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0203-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0203-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0203-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0203-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0203-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0203-1 110d247fa046…a55b01930146…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZAFIRLUKAST ACTIVE INGREDIENT XZ629S5L50 ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ZAFIRLUKAST ACTIVE MOIETY XZ629S5L50 ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
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.