Home NDC 68151-1977 Zafirlukast
Product NDC 68151-1977
11-digit product format 681511977
Labeler code 68151
Product ID 68151-1977_768cc9a9-f645-4709-94ea-a915850d40d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zafirlukast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Carilion Materials Management
Application ANDA090372
Marketing category ANDA
Marketing start 2010-11-18
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 No
Listing certified through 2020-12-31
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 · 38 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 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 68151-1977-6 8dfbde2a14a4…c9ff85d89658…
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 A090372-001 ZAFIRLUKAST ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 A090372-002 ZAFIRLUKAST ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18
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 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090372-001 ZAFIRLUKAST 10MG TABLET / ORAL AB 2010-11-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090372-002 ZAFIRLUKAST 20MG TABLET / ORAL AB 2010-11-18 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68151-1977-6 Zafirlukast 1 in 1 PACKAGE TABLET, FILM COATED 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Zafirlukast ACTIVE INGREDIENT XZ629S5L50 ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 Zafirlukast ACTIVE MOIETY XZ629S5L50 ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68151-1977 ZAFIRLUKAST TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 4 Legacy NDC, 1 package rows 20190125_fb546f57-cd2f-4cbf-8c54-fbc23d47fe0f.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 Status 68151-1977-6 68151197706 1 in 1 PACKAGE Historical