MONTELUKAST

Product NDC: 0143-9650
11-digit product format: 001439650
Labeler code: 0143
Product ID: 0143-9650_88edb668-e5cc-4bdc-8cb0-622ebed87063
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MONTELUKAST
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: West ward Pharmaceutical Corp
Application: ANDA203037
Marketing category: ANDA
Marketing start: 2014-12-01
Marketing end: 0000-00-00
Substance: MONTELUKAST SODIUM
Active strength: 5 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0143-9650		I	Inactivated by FDA	2026-08-11
excluded package	package	0143-9650	0143-9650-09	I	Inactivated by FDA	2026-08-11
excluded package	package	0143-9650	0143-9650-10	I	Inactivated by FDA	2026-08-11
excluded package	package	0143-9650	0143-9650-30	I	Inactivated by FDA	2026-08-11

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 · 88 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	0143-9650-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-9650-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-9650-09	`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	0143-9650-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-9650-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-9650-09	`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	0143-9650-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-9650-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-9650-09	`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	0143-9650-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-9650-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-9650-09	`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	0143-9650-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-9650-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-9650-09	`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	0143-9650-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-9650-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-9650-09	`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	0143-9650-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-9650-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-9650-09	`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	0143-9650-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-9650-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-9650-09	`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	0143-9650-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-9650-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-9650-09	`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	0143-9650-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-9650-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-9650-09	`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	0143-9650-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-9650-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-9650-09	`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	0143-9650-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9650-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9650-09	`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	0143-9650-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0143-9650-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0143-9650-09	`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	0143-9650-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0143-9650-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0143-9650-09	`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	0143-9650-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0143-9650-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0143-9650-09	`1332a3947898…`	`d4bfe170f9cd…`

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
A203037-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2014-10-30
A203037-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2014-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203037-001	AB
A203037-002	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	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203037-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203037-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2014-10-30	`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	A203037-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203037-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203037-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203037-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203037-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203037-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203037-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203037-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203037-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203037-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203037-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203037-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203037-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203037-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203037-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203037-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203037-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203037-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203037-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203037-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203037-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203037-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203037-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203037-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203037-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203037-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203037-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203037-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203037-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203037-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203037-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203037-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203037-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203037-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203037-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203037-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203037-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203037-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203037-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203037-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0143-9650-09	2020-01-31	C162847	48780-1	9d75b9d0-21fd-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998
0143-9650-10	2020-01-31	C162847	48780-1	9d75b9d0-21fd-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998
0143-9650-30	2020-01-31	C162847	48780-1	9d75b9d0-21fd-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0143-9650-09	MONTELUKAST	90 in 1 BOTTLE	TABLET, CHEWABLE	90	3
0143-9650-10	MONTELUKAST	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000	3
0143-9650-30	MONTELUKAST	30 in 1 BOTTLE	TABLET, CHEWABLE	30	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9650-09	EA - Each	0143-9650	81d4d128-9106-4527-9eee-3707e8eee728	1	2015-07-20
0143-9650-10	EA - Each	0143-9650	7d0b2ad7-489b-4c8e-b316-a421157294f8	1	2015-07-20
0143-9650-30	EA - Each	0143-9650	2186d6c0-dade-4759-b08c-9524045b701a	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9650	MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]	3	Legacy NDC, 3 package rows	20151030_43b80e54-bd48-46f0-835e-b055e797a8c0.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	MONTELUKAST	Proficient Rx LP	9705627c-283e-4743-b261-cfeb88d96e9b	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203037 application number: ANDA203037

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200224	montelukast sodium 10 MG Oral Tablet	PSN	43b80e54-bd48-46f0-835e-b055e797a8c0	3
311759	montelukast sodium 4 MG Chewable Tablet	PSN	43b80e54-bd48-46f0-835e-b055e797a8c0	3
242438	montelukast sodium 5 MG Chewable Tablet	PSN	43b80e54-bd48-46f0-835e-b055e797a8c0	3
242438	montelukast sodium 5 MG Chewable Tablet	PSN	9705627c-283e-4743-b261-cfeb88d96e9b	3
200224	montelukast 10 MG Oral Tablet	SCD	43b80e54-bd48-46f0-835e-b055e797a8c0	3
311759	montelukast 4 MG Chewable Tablet	SCD	43b80e54-bd48-46f0-835e-b055e797a8c0	3
242438	montelukast 5 MG Chewable Tablet	SCD	43b80e54-bd48-46f0-835e-b055e797a8c0	3
242438	montelukast 5 MG Chewable Tablet	SCD	9705627c-283e-4743-b261-cfeb88d96e9b	3
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	43b80e54-bd48-46f0-835e-b055e797a8c0	3
311759	montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet	SY	43b80e54-bd48-46f0-835e-b055e797a8c0	3
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	43b80e54-bd48-46f0-835e-b055e797a8c0	3
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	9705627c-283e-4743-b261-cfeb88d96e9b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0143-9650-09	00143965009	90 in 1 BOTTLE	Historical
0143-9650-10	00143965010	1000 in 1 BOTTLE	Historical
0143-9650-30	00143965030	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MONTELUKAST	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
MONTELUKAST	West ward Pharmaceutical Corp \| Unimark Remedies Ltd. \| Alkem Laboratories Limited. \| Kemwell Biopharma Private Limited	2015-06-24	HUMAN PRESCRIPTION DRUG LABEL	3