montelukast sodium

Product NDC: 50090-7920
11-digit product format: 500907920
Labeler code: 50090
Product ID: 50090-7920_c678afd8-0ddd-40a3-936e-594c126a275d
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 1.

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
A204093-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2015-05-22
A204093-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2015-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204093-001	AB
A204093-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204093-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204093-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204093-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204093-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204093-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204093-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204093-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204093-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204093-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204093-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204093-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204093-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204093-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204093-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204093-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MONTELUKAST	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MHM278SD3E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
04b3faff-1ea1-4d2a-aa31-9d6e742e1759	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
8d8a355b-240d-8c38-7331-c9e3c1068a33	Product name	9	20161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7920-0	montelukast sodium	30 in 1 BOTTLE	TABLET, CHEWABLE	30		1
50090-7920-1	montelukast sodium	90 in 1 BOTTLE	TABLET, CHEWABLE	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7920-0	EA - Each	50090-7920	1fe7873b-6864-443a-ae70-e2a03bad0835	1	2026-04-20
50090-7920-1	EA - Each	50090-7920	99362c96-be4f-458b-bd6a-8716762e0e51	1	2026-04-20

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	7ff11e37-9ea5-40b6-96f7-4caf27cab756	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	1a312a28-8472-4cab-a7dd-d01cd8b2765a	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	25b2049d-3a93-4ac3-8de6-14f5d7ce0315	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	04b3faff-1ea1-4d2a-aa31-9d6e742e1759	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093 ndc (product): 50090-7920
montelukast sodium	MONTELUKAST SODIUM	Preferred Pharmaceuticals, Inc.	09b0bc9e-3035-45b4-b61b-4aca70848360	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	c2d834e6-7b38-d266-e053-2995a90a27ef	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	3ff4100f-11e3-4d6a-ab88-83bd605a1818	2024-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	Camber Pharmaceuticals, Inc.	23964723-2df8-4d0a-a53d-8538469672f1	2021-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MHM278SD3E	MONTELUKAST	158966-92-8	MONTELUKAST
U1O3J18SFL	MONTELUKAST SODIUM	151767-02-1	montelukast sodium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311759	montelukast sodium 4 MG Chewable Tablet	PSN	04b3faff-1ea1-4d2a-aa31-9d6e742e1759	1
311759	montelukast 4 MG Chewable Tablet	SCD	04b3faff-1ea1-4d2a-aa31-9d6e742e1759	1
311759	montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet	SY	04b3faff-1ea1-4d2a-aa31-9d6e742e1759	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7920-0	50090792000	30 TABLET, CHEWABLE in 1 BOTTLE (50090-7920-0)	2026-03-03	No	No	Current
50090-7920-1	50090792001	90 TABLET, CHEWABLE in 1 BOTTLE (50090-7920-1)	2026-03-03	No	No	Current