Montelukast Sodium

Product NDC: 63187-896
11-digit product format: 631870896
Labeler code: 63187
Product ID: 63187-896_c1e8f3ed-105b-4abd-a99e-6a8ebfd6edaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA200405
Marketing category: ANDA
Marketing start: 2012-08-03
Substance: MONTELUKAST SODIUM
Active strength: 5 mg/1
Pharmacologic classes: Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200405-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2012-08-03
A200405-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2012-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200405-001	AB
A200405-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200405-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200405-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2012-08-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200405-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200405-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200405-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200405-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200405-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200405-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200405-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200405-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200405-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200405-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200405-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200405-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200405-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200405-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200405-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200405-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200405-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200405-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200405-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200405-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200405-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200405-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200405-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200405-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200405-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200405-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200405-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200405-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200405-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200405-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200405-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200405-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200405-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200405-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200405-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200405-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200405-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200405-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200405-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200405-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Montelukast Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MONTELUKAST SODIUM	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U1O3J18SFL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242438	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
0f2dbf17-bce0-4e09-8c22-898d93be80da	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	SPL version
63187-896-30	Montelukast Sodium	30 in 1 BOTTLE	TABLET, CHEWABLE	30	3
63187-896-60	Montelukast Sodium	60 in 1 BOTTLE	TABLET, CHEWABLE	60	3
63187-896-90	Montelukast Sodium	90 in 1 BOTTLE	TABLET, CHEWABLE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-896-30	EA - Each	63187-896	b8e72b66-26de-4bab-ae32-a558526bb21e	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-896	MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20191108_0f2dbf17-bce0-4e09-8c22-898d93be80da.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Chartwell RX, LLC	5cb4298c-10b1-4d6f-95ad-4aad72daf249	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405
Montelukast Sodium	MONTELUKAST SODIUM	AvKARE	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405
Montelukast Sodium	MONTELUKAST SODIUM	AvPAK	2f90a573-27fd-cc16-f3d1-8c4d630224a0	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405
Montelukast Sodium	MONTELUKAST SODIUM	Lannett Company, Inc.	c43d1edb-c162-4317-9a89-d84e4eff5512	2023-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	83c35a3d-0bbc-4598-bf76-ab0c2903bf19	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	0f2dbf17-bce0-4e09-8c22-898d93be80da	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200405 application number: ANDA200405 ndc (product): 63187-896

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U1O3J18SFL	MONTELUKAST SODIUM	151767-02-1	MONTELUKAST SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
242438	montelukast sodium 5 MG Chewable Tablet	PSN	0f2dbf17-bce0-4e09-8c22-898d93be80da	3
242438	montelukast 5 MG Chewable Tablet	SCD	0f2dbf17-bce0-4e09-8c22-898d93be80da	3
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	0f2dbf17-bce0-4e09-8c22-898d93be80da	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-896-30	63187089630	30 TABLET, CHEWABLE in 1 BOTTLE (63187-896-30)	2017-08-01	0000-00-00	No	No	Current
63187-896-60	63187089660	60 TABLET, CHEWABLE in 1 BOTTLE (63187-896-60)	2017-08-01	0000-00-00	No	No	Current
63187-896-90	63187089690	90 TABLET, CHEWABLE in 1 BOTTLE (63187-896-90)	2017-08-01	0000-00-00	No	No	Current