Montelukast Sodium

Product NDC: 70436-090
11-digit product format: 704360090
Labeler code: 70436
Product ID: 70436-090_a672fe2a-6e74-1a83-e053-2995a90a9610
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Slate Run Pharmaceuticals, LLC.
Application: ANDA205695
Marketing category: ANDA
Marketing start: 2018-03-13
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: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70436-090		D	Discontinued by firm		2026-08-17
excluded package	package	70436-090	70436-090-06	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70436-090-06	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70436-090-06	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70436-090-06	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70436-090-06	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70436-090-06	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70436-090-06	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70436-090-06	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70436-090-06	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70436-090-06	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70436-090-06	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70436-090-06	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70436-090-06	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A205695-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2015-11-05
A205695-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2015-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205695-001	AB
A205695-002	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	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205695-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205695-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-11-05	`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	A205695-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205695-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205695-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205695-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205695-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205695-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205695-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205695-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205695-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205695-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205695-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205695-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205695-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205695-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205695-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205695-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205695-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205695-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205695-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205695-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205695-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205695-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205695-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205695-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205695-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205695-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205695-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205695-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205695-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205695-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205695-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205695-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205695-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205695-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205695-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205695-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205695-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205695-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205695-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205695-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70436-090-06	2023-02-17	C162847	48780-1	d6a99b39-3e9c-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM Chewable Tablets, for oral use Initial U.S. Approval: 1998
70436-090-06	2022-01-28	C162847	48780-1	d6a99b39-3e9c-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM Chewable Tablets, for oral use Initial U.S. Approval: 1998

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70436-090-06	EA - Each	70436-090	6c12233f-1c58-4189-845a-83754bffd2d7	1	2019-01-24

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70436-090-06	70436009006	90 TABLET, CHEWABLE in 1 BOTTLE (70436-090-06)	2018-03-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Montelukast Sodium	Slate Run Pharmaceuticals, LLC. \| Anbison laboratory Co. Ltd.	2023-06-28	HUMAN PRESCRIPTION DRUG LABEL	8