Montelukast Sodium

Product NDC
63629-4855
11-digit product format
636294855
Labeler code
63629
Product ID
63629-4855_3489a7de-e6b4-4c7c-8837-958d692a29bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201508
Marketing category
ANDA
Marketing start
2012-08-03
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
4 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-4855DDiscontinued by firm2026-10-05
excluded packagepackage63629-485563629-4855-1DDiscontinued by firm2026-10-05
excluded packagepackage63629-485563629-4855-2DDiscontinued by firm2026-10-05
excluded packagepackage63629-485563629-4855-3DDiscontinued by firm2026-10-05

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 · 57 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4855-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4855-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4855-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4855-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4855-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4855-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4855-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4855-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4855-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4855-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4855-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4855-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4855-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4855-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4855-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4855-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4855-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4855-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4855-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4855-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4855-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4855-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4855-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4855-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4855-3DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4855-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4855-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-4855-3DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-4855-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-4855-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-4855-3DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-4855-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-4855-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-4855-3DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-4855-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-4855-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-4855-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-4855-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4855-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4855-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-4855-2IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-4855-1IInactivated by FDA110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201508-001MONTELUKAST SODIUMMONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-03
A201508-002MONTELUKAST SODIUMMONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-0384e616aacf4f…
2026-09-14 22:38:342026-08A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-0384e616aacf4f…
2026-08-18 06:07:402026-07A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201508-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORAL2012-08-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201508-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORAL2012-08-0374a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001