montelukast sodium

Product NDC: 68788-7771
Requested package NDC: 68788-7771-6
11-digit product format: 687887771
Labeler code: 68788
Product ID: 68788-7771_fc1d0567-9524-43c8-929d-fd093936abc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: montelukast sodium
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA204093
Marketing category: ANDA
Marketing start: 2020-08-03
Marketing end: 0000-00-00
Substance: MONTELUKAST
Active strength: 4 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	68788-7771	68788-7771-6	D	Discontinued by firm		2026-08-11

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
A204093-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2015-05-22
A204093-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2015-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204093-001	AB
A204093-002	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 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	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204093-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204093-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2015-05-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A204093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204093-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204093-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204093-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204093-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204093-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204093-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204093-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204093-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204093-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204093-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204093-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204093-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204093-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204093-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204093-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204093-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204093-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204093-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204093-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204093-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204093-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204093-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204093-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204093-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204093-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204093-002	AB	1	`782e0a99824c…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7771	MONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.]	5	Legacy NDC	20240724_4351bd67-99df-4327-b98d-bf23cc989904.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	7ff11e37-9ea5-40b6-96f7-4caf27cab756	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	1a312a28-8472-4cab-a7dd-d01cd8b2765a	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	25b2049d-3a93-4ac3-8de6-14f5d7ce0315	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	A-S Medication Solutions	04b3faff-1ea1-4d2a-aa31-9d6e742e1759	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	Preferred Pharmaceuticals, Inc.	09b0bc9e-3035-45b4-b61b-4aca70848360	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
MONTELUKAST SODIUM	MONTELUKAST SODIUM	DIRECT RX	c2d834e6-7b38-d266-e053-2995a90a27ef	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	Bryant Ranch Prepack	3ff4100f-11e3-4d6a-ab88-83bd605a1818	2024-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093
montelukast sodium	MONTELUKAST SODIUM	Camber Pharmaceuticals, Inc.	23964723-2df8-4d0a-a53d-8538469672f1	2021-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204093 application number: ANDA204093

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MHM278SD3E	MONTELUKAST	158966-92-8	MONTELUKAST
U1O3J18SFL	MONTELUKAST SODIUM	151767-02-1	montelukast sodium

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7771-6	68788777106	60 TABLET, CHEWABLE in 1 BOTTLE (68788-7771-6)	2020-08-03	0000-00-00	No	No	Current