Montelukast Sodium

Product NDC: 63629-8106
Requested package NDC: 63629-8106-2
11-digit product format: 636298106
Labeler code: 63629
Product ID: 63629-8106_b8b86f2b-1fe3-4a58-9bf4-e826166609c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202717
Marketing category: ANDA
Marketing start: 2013-04-11
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-8106	63629-8106-2	I	Inactivated by FDA		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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 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	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202717-001	AB	1	`caaa826d4ba7…`
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…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-8106-1	2024-01-30	C162847	48780-1	1030e365-1c7a-111a-e063-dadaa90a10e2	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
63629-8106-2	2024-01-30	C162847	48780-1	1030e365-1c7a-111a-e063-dadaa90a10e2	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8106-1	Montelukast Sodium	30 in 1 BOTTLE	TABLET, FILM COATED	30		2
63629-8106-2	Montelukast Sodium	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8106	MONTELUKAST SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]	2	Legacy NDC, 2 package rows	20220119_b8b86f2b-1fe3-4a58-9bf4-e826166609c3.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
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	b8b86f2b-1fe3-4a58-9bf4-e826166609c3	2
200224	montelukast 10 MG Oral Tablet	SCD	b8b86f2b-1fe3-4a58-9bf4-e826166609c3	2
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	b8b86f2b-1fe3-4a58-9bf4-e826166609c3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8106-2	63629810602	90 TABLET, FILM COATED in 1 BOTTLE (63629-8106-2)	2019-07-15	0000-00-00	No	No	Current