Home NDC 55111-625 Zafirlukast
Product NDC 55111-625
11-digit product format 551110625
Labeler code 55111
Product ID 55111-625_b5fb9efb-3369-e1f9-384c-bd22e8ecad92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zafirlukast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddys Laboratories Limited
Application ANDA090372
Marketing category ANDA
Marketing start 2010-11-18
Substance ZAFIRLUKAST
Active strength 10 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 1 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 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199655 Internal RxNorm lookup 313758 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 55111-625-01 Zafirlukast 100 in 1 BOTTLE TABLET, FILM COATED 100 9 55111-625-05 Zafirlukast 500 in 1 BOTTLE TABLET, FILM COATED 500 9 55111-625-30 Zafirlukast 30 in 1 BOTTLE TABLET, FILM COATED 30 9 55111-625-60 Zafirlukast 60 in 1 BOTTLE TABLET, FILM COATED 60 9 55111-625-78 Zafirlukast 10 in 1 CARTON TABLET, FILM COATED 10 9 55111-625-79 Zafirlukast 10 in 1 BLISTER PACK TABLET, FILM COATED 10 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Zafirlukast ACTIVE INGREDIENT XZ629S5L50 ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 Zafirlukast ACTIVE MOIETY XZ629S5L50 ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-625 ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 9 Current NDC, Legacy NDC, 6 package rows 20190312_6ccb96af-2647-9206-5eee-49a825d32488.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 55111-625-01 55111062501 100 TABLET, FILM COATED in 1 BOTTLE (55111-625-01) 2010-11-18 0000-00-00 No No Current 55111-625-05 55111062505 500 TABLET, FILM COATED in 1 BOTTLE (55111-625-05) 2010-11-18 0000-00-00 No No Current 55111-625-30 55111062530 30 TABLET, FILM COATED in 1 BOTTLE (55111-625-30) 2010-11-18 0000-00-00 No No Current 55111-625-60 55111062560 60 TABLET, FILM COATED in 1 BOTTLE (55111-625-60) 2010-11-18 0000-00-00 No No Current 55111-625-78 55111062578 10 BLISTER PACK in 1 CARTON (55111-625-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-625-79) 10 blister pack 2010-11-18 0000-00-00 No No Current 55111-625-79 55111062579 10 in 1 BLISTER PACK Historical