Home NDC 63629-4886-5 Montelukast
Product NDC 63629-4886
Requested package NDC 63629-4886-5
11-digit product format 636294886
Labeler code 63629
Product ID 63629-4886_e67c211a-cee7-41e8-9a2a-32d7363ef2a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA200889
Marketing category ANDA
Marketing start 2012-08-03
Marketing end 0000-00-00
Substance MONTELUKAST SODIUM
Active strength 10 mg/1
Pharmacologic classes 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 · 19 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200889-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200889-001 AB
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-4886-1 2024-01-30 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-2 2024-01-30 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-3 2024-01-30 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-4 2024-01-30 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-5 2024-01-30 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-6 2024-01-30 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-7 2024-01-30 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-8 2024-01-30 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-1 2022-02-16 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-2 2022-02-16 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-3 2022-02-16 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-4 2022-02-16 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-5 2022-02-16 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-6 2022-02-16 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-1 2019-11-27 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-2 2019-11-27 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-3 2019-11-27 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-4 2019-11-27 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-5 2019-11-27 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 63629-4886-6 2019-11-27 These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-4886-1 Montelukast 30 in 1 BOTTLE TABLET, FILM COATED 30 1002 63629-4886-2 Montelukast 4 in 1 BOTTLE TABLET, FILM COATED 4 1002 63629-4886-3 Montelukast 7 in 1 BOTTLE TABLET, FILM COATED 7 1002 63629-4886-4 Montelukast 60 in 1 BOTTLE TABLET, FILM COATED 60 1002 63629-4886-5 Montelukast 10 in 1 BOTTLE TABLET, FILM COATED 10 1002 63629-4886-6 Montelukast 90 in 1 BOTTLE TABLET, FILM COATED 90 1002 63629-4886-7 Montelukast 120 in 1 BOTTLE TABLET, FILM COATED 120 1002 63629-4886-8 Montelukast 15 in 1 BOTTLE TABLET, FILM COATED 15 1002
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-4886 MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1002 Legacy NDC, 8 package rows 20220217_e67c211a-cee7-41e8-9a2a-32d7363ef2a3.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-4886-5 63629488605 10 TABLET, FILM COATED in 1 BOTTLE (63629-4886-5) 2022-02-08 0000-00-00 No No Current