Home NDC 64380-178 ACCOLATE
Product NDC 64380-178
11-digit product format 643800178
Labeler code 64380
Product ID 64380-178_bd60d8ba-4d06-49e6-898a-0d05de6078c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zafirlukast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Strides Pharma Science Limited
Application NDA020547
Marketing category NDA
Marketing start 2023-01-02
Marketing end 0000-00-00
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 2023-12-31
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 · 4 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 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 64380-178-01 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 64380-178-01 1332a3947898…d4bfe170f9cd…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-178 ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] 3 Legacy NDC 20250323_3bbd0e85-6014-46cd-a363-60102c4bc5a2.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64380-178-01 64380017801 60 TABLET, FILM COATED in 1 BOTTLE (64380-178-01) 2023-01-02 0000-00-00 No No Current