montelukast sodium

Product NDC
50090-2921
11-digit product format
500902921
Labeler code
50090
Product ID
50090-2921_2080cbb8-f8f8-4ad7-ac99-74d59ba79bd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204093
Marketing category
ANDA
Marketing start
2015-05-27
Substance
MONTELUKAST
Active strength
4 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204093-001MONTELUKAST SODIUMMONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22
A204093-002MONTELUKAST SODIUMMONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204093-001AB
A204093-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204093-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204093-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204093-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204093-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204093-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204093-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204093-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204093-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204093-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204093-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204093-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204093-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204093-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204093-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204093-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204093-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204093-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204093-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204093-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204093-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204093-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204093-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204093-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204093-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204093-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204093-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204093-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204093-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204093-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204093-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204093-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204093-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204093-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204093-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204093-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204093-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204093-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204093-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204093-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204093-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
montelukast sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MHM278SD3EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311759Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25b2049d-3a93-4ac3-8de6-14f5d7ce0315Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2921-0montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE3017
50090-2921-1montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2921-0EA - Each50090-29215b8f2e5d-c321-4eb0-8e74-03a763f63b3b12021-08-05
50090-2921-1EA - Each50090-292113fa1e5b-d3d2-45f5-9a10-58b44c3c792e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2921MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20240530_25b2049d-3a93-4ac3-8de6-14f5d7ce0315.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions7ff11e37-9ea5-40b6-96f7-4caf27cab7562026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204093
application number: ANDA204093
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions1a312a28-8472-4cab-a7dd-d01cd8b2765a2026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204093
application number: ANDA204093
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions25b2049d-3a93-4ac3-8de6-14f5d7ce03152026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204093
application number: ANDA204093
ndc (product): 50090-2921
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions04b3faff-1ea1-4d2a-aa31-9d6e742e17592026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204093
application number: ANDA204093
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals, Inc.09b0bc9e-3035-45b4-b61b-4aca708483602026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204093
application number: ANDA204093
MONTELUKAST SODIUMMONTELUKAST SODIUMDIRECT RXc2d834e6-7b38-d266-e053-2995a90a27ef2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204093
application number: ANDA204093
montelukast sodiumMONTELUKAST SODIUMBryant Ranch Prepack3ff4100f-11e3-4d6a-ab88-83bd605a18182024-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204093
application number: ANDA204093
montelukast sodiumMONTELUKAST SODIUMCamber Pharmaceuticals, Inc.23964723-2df8-4d0a-a53d-8538469672f12021-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204093
application number: ANDA204093

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSN25b2049d-3a93-4ac3-8de6-14f5d7ce031517
311759montelukast 4 MG Chewable TabletSCD25b2049d-3a93-4ac3-8de6-14f5d7ce031517
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY25b2049d-3a93-4ac3-8de6-14f5d7ce031517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2921-05009029210030 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-0) 2017-03-150000-00-00NoNoCurrent
50090-2921-15009029210190 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-1) 2018-10-050000-00-00NoNoCurrent