Montelukast

Product NDC: 50268-556
11-digit product format: 502680556
Labeler code: 50268
Product ID: 50268-556_47e755f4-d852-60b7-e063-6294a90aa1e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA202843
Marketing category: ANDA
Marketing start: 2022-02-08
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 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…`

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
d7870c45-5a8b-8369-e053-2a95a90ae1f3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8d8a355b-240d-8c38-7331-c9e3c1068a33	Product name	9	20161220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-556-11	Montelukast	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		4
50268-556-15	Montelukast	50 in 1 BOX	TABLET, FILM COATED	50		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-556-11	EA - Each	50268-556	ef42f378-7fbf-4b60-8fcc-65d1ab2b26df	1	2022-03-09
50268-556-15	EA - Each	50268-556	721227fa-5aba-4a45-9fe0-f2c7192a5a62	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-556	MONTELUKAST TABLET, FILM COATED [AVPAK]	3	Current NDC, Legacy NDC, 2 package rows	20240110_d7870c45-5a8b-8369-e053-2a95a90ae1f3.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 ndc (product): 50268-556
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200224	montelukast sodium 10 MG Oral Tablet	PSN	d7870c45-5a8b-8369-e053-2a95a90ae1f3	4
200224	montelukast 10 MG Oral Tablet	SCD	d7870c45-5a8b-8369-e053-2a95a90ae1f3	4
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	d7870c45-5a8b-8369-e053-2a95a90ae1f3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-556-11	50268055611	1 in 1 BLISTER PACK						Historical
50268-556-15	50268055615	50 BLISTER PACK in 1 BOX (50268-556-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-556-11)	50 blister pack	2022-02-08	0000-00-00	No	No	Current