montelukast sodium

Product NDC
68788-7669
11-digit product format
687887669
Labeler code
68788
Product ID
68788-7669_f9ab7e9f-ce5e-4c52-919e-66602d0c719e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204093
Marketing category
ANDA
Marketing start
2020-02-28
Substance
MONTELUKAST
Active strength
5 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 1.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A204093-001MONTELUKAST SODIUMEQ 4MG BASETABLET, CHEWABLE / ORALAB2015-05-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A204093-002MONTELUKAST SODIUMEQ 5MG BASETABLET, CHEWABLE / ORALAB2015-05-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A204093-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204093-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST5 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
242438Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09b0bc9e-3035-45b4-b61b-4aca70848360Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7669-1montelukast sodium10 in 1 BOTTLETABLET, CHEWABLE106
68788-7669-2montelukast sodium20 in 1 BOTTLETABLET, CHEWABLE206
68788-7669-3montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE306
68788-7669-4montelukast sodium14 in 1 BOTTLETABLET, CHEWABLE146
68788-7669-6montelukast sodium60 in 1 BOTTLETABLET, CHEWABLE606
68788-7669-9montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7669-1EA - Each68788-7669d130ce6b-a2ca-45d0-a0a8-17e7747895cc12020-05-08
68788-7669-2EA - Each68788-76697464d2ce-011e-4809-8c93-bd9002fb3eb912020-05-08
68788-7669-3EA - Each68788-76697f8181e8-7f69-4d34-a1cb-390fe7cba86b12020-05-08
68788-7669-4EA - Each68788-76696fced204-8cfd-4b4a-9661-6e6b836bf86612020-05-08
68788-7669-6EA - Each68788-766955367211-9966-44f2-a1cb-1b734d89400712020-05-08
68788-7669-9EA - Each68788-766953c0e2ee-c978-4e3c-880d-1dd89588f57012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7669MONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 6 package rows20240724_09b0bc9e-3035-45b4-b61b-4aca70848360.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
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
ndc (product): 68788-7669
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
242438montelukast sodium 5 MG Chewable TabletPSN09b0bc9e-3035-45b4-b61b-4aca708483606
242438montelukast 5 MG Chewable TabletSCD09b0bc9e-3035-45b4-b61b-4aca708483606
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY09b0bc9e-3035-45b4-b61b-4aca708483606

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7669-16878876690110 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-1) 2020-02-280000-00-00NoNoCurrent
68788-7669-26878876690220 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-2) 2020-02-280000-00-00NoNoCurrent
68788-7669-36878876690330 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-3) 2020-02-280000-00-00NoNoCurrent
68788-7669-46878876690414 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-4) 2020-02-280000-00-00NoNoCurrent
68788-7669-66878876690660 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-6) 2020-02-280000-00-00NoNoCurrent
68788-7669-96878876690990 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-9) 2020-02-280000-00-00NoNoCurrent