Montelukast Sodium

Product NDC: 0054-0259
11-digit product format: 000540259
Labeler code: 0054
Product ID: 0054-0259_c91cde13-9b1f-402a-b1bd-920fedfade4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA090655
Marketing category: ANDA
Marketing start: 2012-08-03
Marketing end: 2021-02-28
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: 0000-00-00
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	0054-0259		D	Discontinued by firm	2026-08-17
excluded package	package	0054-0259	0054-0259-13	D	Discontinued by firm	2026-08-17
excluded package	package	0054-0259	0054-0259-22	D	Discontinued by firm	2026-08-17
excluded package	package	0054-0259	0054-0259-31	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 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	0054-0259-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0259-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0259-22	`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	0054-0259-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0259-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0259-22	`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	0054-0259-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0259-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0259-22	`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	0054-0259-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0259-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0259-22	`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	0054-0259-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0259-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0259-22	`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	0054-0259-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0259-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0259-22	`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	0054-0259-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0259-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0259-22	`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	0054-0259-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0259-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0259-22	`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	0054-0259-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0259-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0259-22	`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	0054-0259-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-0259-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-0259-22	`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	0054-0259-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-0259-13	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-0259-22	`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	0054-0259-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0054-0259-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0054-0259-22	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090655-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL			2012-08-03

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090655-001	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	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090655-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL		2012-08-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090655-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090655-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090655-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090655-001	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0259-13	EA - Each	0054-0259	8b4405d8-5bd2-445a-8ec2-40da5ac04c0b	1	2013-02-13
0054-0259-22	EA - Each	0054-0259	7f90a7dd-11f8-4e31-8198-67c9a93df8d1	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 TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]	2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0259-22	00054025922	90 TABLET in 1 BOTTLE (0054-0259-22)	90 tablet	2012-08-03	2021-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Montelukast Sodium	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2021-03-02	HUMAN PRESCRIPTION DRUG LABEL	11
Montelukast Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	2016-06-22	HUMAN PRESCRIPTION DRUG LABEL	1