montelukast sodium

Product NDC: 29300-222
11-digit product format: 293000222
Labeler code: 29300
Product ID: 29300-222_c2311308-5e7d-44e4-91b7-5a6d653be28f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: montelukast sodium
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA208621
Marketing category: ANDA
Marketing start: 2018-08-20
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208621-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB		2018-07-02
A208621-002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB		2018-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208621-001	AB
A208621-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL		2018-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208621-001	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208621-002	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE / ORAL	AB	2018-07-02	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A208621-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208621-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208621-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208621-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208621-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208621-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208621-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208621-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208621-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208621-002	AB	1	`31067a03dcf5…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208621-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208621-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208621-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208621-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208621-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208621-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208621-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208621-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208621-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208621-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208621-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208621-002	AB	1	`782e0a99824c…`
2020-11-12 02:37 UTC	2020-11	A208621-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208621-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208621-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208621-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208621-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208621-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208621-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208621-002	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208621-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208621-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208621-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208621-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208621-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208621-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208621-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208621-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208621-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208621-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: montelukast sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MONTELUKAST SODIUM	5 mg/1

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	SPL version
29300-222-10	montelukast sodium	1000 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	1000	17
29300-222-13	montelukast sodium	30 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	30	17
29300-222-19	montelukast sodium	90 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	90	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-222-10	EA - Each	29300-222	f7a234a0-759c-4166-b0fb-e08e3ce4e634	1	2019-01-24
29300-222-13	EA - Each	29300-222	4ee07bab-3e92-4292-8d12-208229a8c981	1	2019-01-24
29300-222-19	EA - Each	29300-222	c36267ae-a1ea-47df-9d40-eb053cdbeba8	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-222	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [UNICHEM PHARMACEUTICALS (USA), INC.]	17	Current NDC, Legacy NDC, 3 package rows	20230625_9e375c07-70db-458c-9336-22a7037b0a5f.zip

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	9e375c07-70db-458c-9336-22a7037b0a5f	17
311759	montelukast sodium 4 MG Chewable Tablet	PSN	9e375c07-70db-458c-9336-22a7037b0a5f	17
242438	montelukast sodium 5 MG Chewable Tablet	PSN	9e375c07-70db-458c-9336-22a7037b0a5f	17
200224	montelukast 10 MG Oral Tablet	SCD	9e375c07-70db-458c-9336-22a7037b0a5f	17
311759	montelukast 4 MG Chewable Tablet	SCD	9e375c07-70db-458c-9336-22a7037b0a5f	17
242438	montelukast 5 MG Chewable Tablet	SCD	9e375c07-70db-458c-9336-22a7037b0a5f	17
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	9e375c07-70db-458c-9336-22a7037b0a5f	17
311759	montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet	SY	9e375c07-70db-458c-9336-22a7037b0a5f	17
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	9e375c07-70db-458c-9336-22a7037b0a5f	17
242438	montelukast sodium 5 MG Chewable Tablet	PSN	b584f59e-2137-4786-8365-1e41e4c3c7db	2
242438	montelukast 5 MG Chewable Tablet	SCD	b584f59e-2137-4786-8365-1e41e4c3c7db	2
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	b584f59e-2137-4786-8365-1e41e4c3c7db	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-222-10	29300022210	1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-10)	2018-08-20	0000-00-00	No	No	Current
29300-222-13	29300022213	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-13)	2018-08-20	0000-00-00	No	No	Current
29300-222-19	29300022219	90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-19)	2018-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
montelukast sodium	Unichem Pharmaceuticals (USA), Inc.	2026-09-28	HUMAN PRESCRIPTION DRUG LABEL	18
montelukast sodium	A-S Medication Solutions	2021-10-09	HUMAN PRESCRIPTION DRUG LABEL	2