Montelukast Sodium

Product NDC: 42291-621
11-digit product format: 422910621
Labeler code: 42291
Product ID: 42291-621_e0c9ae0c-a36e-5ae4-e053-2995a90a0592
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA201522
Marketing category: ANDA
Marketing start: 2012-08-13
Marketing end: 0000-00-00
Substance: MONTELUKAST SODIUM
Active strength: 10 mg/1
Pharmacologic classes: Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42291-621		D	Discontinued by firm	2026-08-10
excluded package	package	42291-621	42291-621-10	D	Discontinued by firm	2026-08-10
excluded package	package	42291-621	42291-621-30	D	Discontinued by firm	2026-08-10
excluded package	package	42291-621	42291-621-55	D	Discontinued by firm	2026-08-10
excluded package	package	42291-621	42291-621-90	D	Discontinued by firm	2026-08-10

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-621-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-621-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-621-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-621-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-621-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-621-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-621-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-621-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-621-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-621-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-621-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-621-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-621-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-621-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-621-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-621-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-621-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-621-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-621-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-621-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-621-55	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-621-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-621-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-621-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-621-55	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-621-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-621-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-621-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-621-55	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-621-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-621-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-621-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-621-55	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-621-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-621-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-621-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-621-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-621-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-621-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-621-55	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-621-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-621-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-621-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-621-55	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-621-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-621-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-621-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-621-55	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201522-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2012-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201522-001	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 2 · 41 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	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201522-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A201522-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201522-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201522-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201522-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201522-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201522-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201522-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201522-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201522-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201522-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201522-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201522-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201522-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201522-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201522-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201522-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201522-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201522-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201522-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201522-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201522-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201522-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201522-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201522-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201522-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201522-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201522-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201522-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201522-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201522-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201522-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201522-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201522-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201522-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201522-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201522-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201522-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201522-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201522-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201522-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
42291-621-10	Montelukast Sodium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	22
42291-621-30	Montelukast Sodium	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
42291-621-55	Montelukast Sodium	5000 in 1 BOTTLE	TABLET, FILM COATED	5000	22
42291-621-90	Montelukast Sodium	90 in 1 BOTTLE	TABLET, FILM COATED	90	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-621-10	EA - Each	42291-621	f9a31652-5623-444b-95ca-0291b8d305d6	1	2013-02-13
42291-621-30	EA - Each	42291-621	34efd6af-d7b9-4518-a9b1-d10d88ece622	1	2013-08-02
42291-621-55	EA - Each	42291-621	b3ad2aca-5373-47d7-8832-31c1450505b3	1	2014-05-02
42291-621-90	EA - Each	42291-621	1ee483e3-5317-450d-a0ca-7fd5ad688f85	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Montelukast Sodium	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
Montelukast	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
Butylated Hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
mannitol	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
sodium stearyl fumarate	INACTIVE INGREDIENT	7CV7WJK4UI	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
talc	INACTIVE INGREDIENT	7SEV7J4R1U	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]	6
Montelukast Sodium	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Montelukast	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
sodium stearyl fumarate	INACTIVE INGREDIENT	7CV7WJK4UI	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-621	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AVKARE]	20	Legacy NDC, 4 package rows	20250112_ed2caffa-a75c-1c27-ae30-2d8280eaea7d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast Sodium	MONTELUKAST SODIUM	AvKARE	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	2025-12-16	Warnings, Adverse reactions	Exact identifier ndc (product): 42291-621

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
200224	montelukast sodium 10 MG Oral Tablet	PSN	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
311759	montelukast sodium 4 MG Chewable Tablet	PSN	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
242438	montelukast sodium 5 MG Chewable Tablet	PSN	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
200224	montelukast 10 MG Oral Tablet	SCD	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
311759	montelukast 4 MG Chewable Tablet	SCD	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
242438	montelukast 5 MG Chewable Tablet	SCD	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
311759	montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet	SY	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	ed2caffa-a75c-1c27-ae30-2d8280eaea7d	22
200224	montelukast sodium 10 MG Oral Tablet	PSN	14d0c576-c5b7-49e4-ba3c-e9f6c8fe5e29	1
200224	montelukast 10 MG Oral Tablet	SCD	14d0c576-c5b7-49e4-ba3c-e9f6c8fe5e29	1
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	14d0c576-c5b7-49e4-ba3c-e9f6c8fe5e29	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-621-10	42291062110	1000 TABLET, FILM COATED in 1 BOTTLE (42291-621-10)	2012-09-14	0000-00-00	No	No	Current
42291-621-30	42291062130	30 in 1 BOTTLE					Historical
42291-621-55	42291062155	5000 in 1 BOTTLE					Historical
42291-621-90	42291062190	90 TABLET, FILM COATED in 1 BOTTLE (42291-621-90)	2012-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Montelukast Sodium	AvKARE	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	22
Montelukast Sodium	Aphena Pharma Solutions - Tennessee, LLC	2014-04-23	HUMAN PRESCRIPTION DRUG LABEL	1