MONTELUKAST SODIUM

Product NDC: 63629-8235
Requested package NDC: 63629-8235-1
11-digit product format: 636298235
Labeler code: 63629
Product ID: 63629-8235_d16b5541-7366-4338-9ca4-06ce26be9619
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MONTELUKAST
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203328
Marketing category: ANDA
Marketing start: 2015-08-13
Marketing end: 0000-00-00
Substance: MONTELUKAST SODIUM
Active strength: 5 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	63629-8235	63629-8235-1	I	Inactivated by FDA		2026-08-11

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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203328-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL			2015-07-31
A203328-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL			2015-07-31

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 3 · 82 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	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203328-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203328-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2015-07-31	`782e0a99824c…`

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	A203328-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203328-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203328-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203328-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203328-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203328-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203328-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203328-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203328-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203328-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203328-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203328-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203328-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203328-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203328-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203328-002	AB	1	`ea99ee380514…`

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
63629-8235-1	2024-01-30	C162847	48780-1	1030e365-3646-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8235-1	MONTELUKAST SODIUM	30 in 1 BOTTLE	TABLET, CHEWABLE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8235	MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE [BRYANT RANCH PREPACK]	2	Legacy NDC, 1 package rows	20220120_d16b5541-7366-4338-9ca4-06ce26be9619.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Ajanta Pharma USA Inc.	67070e4e-f755-46b3-b900-fcc1993a0546	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203328 application number: ANDA203328
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Proficient Rx LP	54014b67-3163-4c8f-b93a-229cd231ca6b	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203328 application number: ANDA203328
MONTELUKAST SODIUM	MONTELUKAST	Proficient Rx LP	cab84c43-96a3-4868-88da-3126685edf00	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203328 application number: ANDA203328

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
242438	montelukast sodium 5 MG Chewable Tablet	PSN	d16b5541-7366-4338-9ca4-06ce26be9619	2
242438	montelukast 5 MG Chewable Tablet	SCD	d16b5541-7366-4338-9ca4-06ce26be9619	2
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	d16b5541-7366-4338-9ca4-06ce26be9619	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8235-1	63629823501	30 TABLET, CHEWABLE in 1 BOTTLE (63629-8235-1)	2019-08-28	0000-00-00	No	No	Current