Montelukast

Product NDC: 68071-2425
11-digit product format: 680712425
Labeler code: 68071
Product ID: 68071-2425_c3660653-6f3e-37a8-e053-2995a90afa1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA202843
Marketing category: ANDA
Marketing start: 2014-09-10
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: 2022-12-31
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	68071-2425		D	Discontinued by firm		2026-08-11
excluded package	package	68071-2425	68071-2425-9	D	Discontinued by firm		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 1 · 30 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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`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	68071-2425-9	`1332a3947898…`	`d4bfe170f9cd…`

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
A202843-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2014-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202843-001	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	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202843-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-10	`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	A202843-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202843-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202843-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202843-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202843-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202843-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202843-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202843-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202843-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202843-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202843-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202843-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202843-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202843-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202843-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202843-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202843-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202843-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202843-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202843-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202843-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202843-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202843-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202843-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202843-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202843-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202843-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202843-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202843-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202843-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202843-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202843-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202843-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202843-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202843-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202843-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202843-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202843-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202843-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202843-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2425-9	2023-01-30	C162847	48780-1	f386c64a-2cf9-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2425	MONTELUKAST TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC	20210529_c36601b4-bc82-f077-e053-2995a90a7b8b.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast	MONTELUKAST	Preferred Pharmaceuticals, Inc.	94642db1-5c75-44c4-92b4-8385b486df82	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast	MONTELUKAST	REMEDYREPACK INC.	ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast	MONTELUKAST	AvPAK	d7870c45-5a8b-8369-e053-2a95a90ae1f3	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
MONTELUKAST	MONTELUKAST SODIUM	A-S Medication Solutions	da9821f1-536a-416b-9594-210bde0cefaf	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast Sodium	MONTELUKAST SODIUM	Cardinal Health 107, LLC	9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast Sodium	MONTELUKAST SODIUM	Major Pharmaceuticals	a4dc63cf-8145-42f4-9437-93b414d2aed4	2025-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Camber Pharmaceuticals, Inc.	97a682c2-7e00-4d07-a5ac-4436c977f842	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast	MONTELUKAST	Quallent Pharmaceuticals Health LLC	5d71088b-b0fa-4bf0-a6e7-6163bd9e0dd4	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Direct_Rx	f3bdf2a3-d661-5128-e053-2995a90a4661	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast	MONTELUKAST	Bryant Ranch Prepack	6b26218d-52a6-4109-90e4-412a17d14fcf	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast	MONTELUKAST	A-S Medication Solutions	6741830f-5d90-4066-bc3b-065059bc150d	2023-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast	MONTELUKAST	XLCare Pharmaceuticals Inc.	82d65eea-c7c9-4e16-9176-46c43f00f0f6	2023-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843
Montelukast	MONTELUKAST	Aphena Pharma Solutions - Tennessee, LLC	4fe3c0d4-94ff-43ca-9d24-54676fe593fe	2021-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202843 application number: ANDA202843

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2425-9	68071242509	90 TABLET, FILM COATED in 1 BOTTLE (68071-2425-9)	2021-05-28	0000-00-00	No	No	Current