Montelukast Sodium

Product NDC: 42254-263
11-digit product format: 422540263
Labeler code: 42254
Product ID: 42254-263_a4f92eb4-0df1-4300-aebd-6082fe804ac8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA201522
Marketing category: ANDA
Marketing start: 2012-08-03
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42254-263		I	Inactivated by FDA	2026-08-07
excluded package	package	42254-263	42254-263-30	I	Inactivated by FDA	2026-08-07
excluded package	package	42254-263	42254-263-90	I	Inactivated by FDA	2026-08-07

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 2 · 66 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	42254-263-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-263-30	`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	42254-263-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-263-30	`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	42254-263-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-263-30	`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	42254-263-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-263-30	`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	42254-263-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-263-30	`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	42254-263-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-263-30	`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	42254-263-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-263-30	`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	42254-263-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-263-30	`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	42254-263-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-263-30	`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	42254-263-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-263-30	`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	42254-263-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-263-30	`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	42254-263-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-263-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-263-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-263-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-263-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-263-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-263-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-263-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-263-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-263-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-263-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-263-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-263-90	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-263-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-263-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-263-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-263-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-263-30	`e2bbac7714bc…`	`27bdfed8d636…`

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
8d8a355b-240d-8c38-7331-c9e3c1068a33	Product name	9	20161220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-263-30	2019-09-24	C162847	48780-1	9350213a-3cfb-c013-e053-90daa90a1393	These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets Initial U.S. approval: 1998
42254-263-90	2019-09-24	C162847	48780-1	9350213a-3cfb-c013-e053-90daa90a1393	These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets Initial U.S. approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-263-30	Montelukast Sodium	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
42254-263-90	Montelukast Sodium	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-263-30	EA - Each	42254-263	52ba33f0-fbdd-4aa4-a9e2-3c4ed5e68ff7	1	2013-04-01
42254-263-90	EA - Each	42254-263	ae2f59fc-4caa-47a4-8846-297fcbff0ba3	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Montelukast Sodium	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
Montelukast	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
hydroxypropyl cellulose (type h)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
sodium stearyl fumarate	INACTIVE INGREDIENT	7CV7WJK4UI	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-263	MONTELUKAST SODIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20130329_a4f92eb4-0df1-4300-aebd-6082fe804ac8.zip

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	a4f92eb4-0df1-4300-aebd-6082fe804ac8	1
200224	montelukast 10 MG Oral Tablet	SCD	a4f92eb4-0df1-4300-aebd-6082fe804ac8	1
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	a4f92eb4-0df1-4300-aebd-6082fe804ac8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-263-30	42254026330	30 in 1 BOTTLE	Historical
42254-263-90	42254026390	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Montelukast Sodium	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-07-17	HUMAN PRESCRIPTION DRUG LABEL	1