Montelukast

Product NDC: 67046-2060
11-digit product format: 670462060
Labeler code: 67046
Product ID: 67046-2060_583a9499-97c0-2ebf-e063-6394a90a35af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA203366
Marketing category: ANDA
Marketing start: 2026-08-04
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203366-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2014-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203366-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203366-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2014-09-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203366-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203366-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203366-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203366-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203366-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203366-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203366-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203366-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203366-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203366-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203366-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203366-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203366-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203366-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203366-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203366-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203366-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203366-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203366-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203366-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203366-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203366-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203366-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203366-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203366-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203366-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203366-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203366-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203366-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203366-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203366-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203366-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203366-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203366-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203366-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203366-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203366-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203366-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203366-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203366-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Montelukast
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MONTELUKAST SODIUM	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U1O3J18SFL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200224	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
583a9499-97f0-2ebf-e063-6394a90a35af	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast	MONTELUKAST	Coupler LLC	583a9499-97f0-2ebf-e063-6394a90a35af	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366 ndc (product): 67046-2060
Montelukast	MONTELUKAST	NuCare Pharmaceuticals, Inc.	365e1c5c-01b2-bf4e-e063-6394a90a0e43	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366
Montelukast	MONTELUKAST	NuCare Pharmaceuticals,Inc.	56429f04-97b6-06a9-e054-00144ff88e88	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366
Montelukast	MONTELUKAST	Macleods Pharmaceuticals Limited	e0c5b856-3f70-4ca6-9763-a90673bb82fb	2023-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366
Montelukast	MONTELUKAST	BluePoint Laboratories	4c411d3e-47b6-481b-b846-419ed4cbb947	2022-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203366 application number: ANDA203366

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	Units	Marketing start	Sample	Exclude flag	Status
67046-2060-3	67046206003	30 TABLET in 1 BLISTER PACK (67046-2060-3)	30 tablet	2026-08-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Montelukast	Coupler LLC \| Macleods Pharmaceuticals Limited	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	1