Home NDC 68084-059 Zafirlukast
Product NDC 68084-059
11-digit product format 680840059
Labeler code 68084
Product ID 68084-059_2434193f-6ba4-923d-e063-6394a90aec0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zafirlukast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA090372
Marketing category ANDA
Marketing start 2013-06-03
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 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 3 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199655 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 68084-059-11 Zafirlukast 1 in 1 BLISTER PACK TABLET, FILM COATED 1 7 68084-059-21 Zafirlukast 30 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 30 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Zafirlukast ACTIVE INGREDIENT XZ629S5L50 ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 Zafirlukast ACTIVE MOIETY XZ629S5L50 ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-059 ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 7 Current NDC, Legacy NDC, 2 package rows 20241013_a60f39f6-d590-4b00-8751-7f12b7ec5385.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 Units Marketing start Marketing end Sample Exclude flag Status 68084-059-11 68084005911 1 in 1 BLISTER PACK Historical 68084-059-21 68084005921 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-059-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-059-11) 30 blister pack 2013-06-03 0000-00-00 No No Current