Montelukast Sodium

Product NDC: 43063-762
Requested package NDC: 43063-762-30
11-digit product format: 430630762
Labeler code: 43063
Product ID: 43063-762_414b7ce2-7550-5e40-e063-6294a90afda2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA202717
Marketing category: ANDA
Marketing start: 2013-04-11
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: 2026-12-31
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
A202717-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2012-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202717-001	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	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`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	A202717-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202717-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202717-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202717-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202717-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202717-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202717-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202717-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202717-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202717-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202717-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202717-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202717-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202717-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202717-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202717-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202717-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202717-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202717-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202717-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202717-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202717-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202717-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202717-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202717-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202717-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202717-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202717-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202717-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202717-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202717-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202717-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202717-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202717-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202717-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202717-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202717-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202717-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202717-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202717-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Montelukast Sodium
Listing expiration: 2026-12-31

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
c9ec1996-6a54-4622-b8a6-57dea49f6b35	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
43063-762-30	Montelukast Sodium	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-762-30	EA - Each	43063-762	1ff9e059-7555-4c58-9ad9-a030883d39d3	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-762	MONTELUKAST SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	21	Current NDC, Legacy NDC, 1 package rows	20241016_c9ec1996-6a54-4622-b8a6-57dea49f6b35.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast Sodium	MONTELUKAST SODIUM	Redpharm Drug	2fbdf1be-a37f-879b-e063-6394a90aa20d	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717
Montelukast Sodium	MONTELUKAST SODIUM	PD-Rx Pharmaceuticals, Inc.	c9ec1996-6a54-4622-b8a6-57dea49f6b35	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717 ndc (package): 43063-762-30 ndc (product): 43063-762 ndc11 (package): 43063076230
Montelukast Sodium	MONTELUKAST SODIUM	NuCare Pharmaceuticals,Inc.	566a8fd7-fc00-2297-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717
Montelukast Sodium	MONTELUKAST SODIUM	NuCare Pharmaceuticals,Inc.	549f1d1a-81f5-29f5-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717
Montelukast Sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	4ba27278-6249-4546-9331-b19302cbf2db	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717
Montelukast Sodium	MONTELUKAST SODIUM	Accord Healthcare Inc.	6eea668f-a2fa-447f-b2d5-4c754d13d9fa	2022-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202717 application number: ANDA202717

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200224	montelukast sodium 10 MG Oral Tablet	PSN	c9ec1996-6a54-4622-b8a6-57dea49f6b35	22
200224	montelukast 10 MG Oral Tablet	SCD	c9ec1996-6a54-4622-b8a6-57dea49f6b35	22
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	c9ec1996-6a54-4622-b8a6-57dea49f6b35	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-762-30	43063076230	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-762-30)	2017-05-04	0000-00-00	No	No	Current