montelukast sodium

Product NDC: 31722-728
Requested package NDC: 31722-728-10
11-digit product format: 317220728
Labeler code: 31722
Product ID: 31722-728_c503ea71-c663-3cfc-e053-2a95a90a9aaa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: montelukast sodium
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA204093
Marketing category: ANDA
Marketing start: 2015-05-27
Substance: MONTELUKAST
Active strength: 5 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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: montelukast sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MONTELUKAST	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MHM278SD3E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242438	Internal RxNorm lookup
311759	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
23964723-2df8-4d0a-a53d-8538469672f1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
8d8a355b-240d-8c38-7331-c9e3c1068a33	Product name	9	20161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-728-01	montelukast sodium	100 in 1 BOTTLE	TABLET, CHEWABLE	100	6
31722-728-10	montelukast sodium	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000	6
31722-728-30	montelukast sodium	30 in 1 BOTTLE	TABLET, CHEWABLE	30	6
31722-728-31	montelukast sodium	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	6
31722-728-32	montelukast sodium	100 in 1 CARTON	TABLET, CHEWABLE	100	6
31722-728-90	montelukast sodium	90 in 1 BOTTLE	TABLET, CHEWABLE	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-728-30	EA - Each	31722-728	e3f3f5e6-a00b-4ee5-a4e9-ac0bce06247e	1	2015-11-12
31722-728-90	EA - Each	31722-728	8a12d0ae-d0f4-442c-9671-ad0de2108b4a	1	2017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MONTELUKAST	ACTIVE INGREDIENT	MHM278SD3E	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-728	MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 6 package rows	20210618_23964723-2df8-4d0a-a53d-8538469672f1.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 ndc (package): 31722-728-10 ndc (product): 31722-728 ndc11 (package): 31722072810

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
242438	montelukast sodium 5 MG Chewable Tablet	PSN	7ff11e37-9ea5-40b6-96f7-4caf27cab756	10
242438	montelukast 5 MG Chewable Tablet	SCD	7ff11e37-9ea5-40b6-96f7-4caf27cab756	10
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	7ff11e37-9ea5-40b6-96f7-4caf27cab756	10
311759	montelukast sodium 4 MG Chewable Tablet	PSN	23964723-2df8-4d0a-a53d-8538469672f1	6
242438	montelukast sodium 5 MG Chewable Tablet	PSN	09b0bc9e-3035-45b4-b61b-4aca70848360	6
242438	montelukast sodium 5 MG Chewable Tablet	PSN	23964723-2df8-4d0a-a53d-8538469672f1	6
311759	montelukast 4 MG Chewable Tablet	SCD	23964723-2df8-4d0a-a53d-8538469672f1	6
242438	montelukast 5 MG Chewable Tablet	SCD	23964723-2df8-4d0a-a53d-8538469672f1	6
242438	montelukast 5 MG Chewable Tablet	SCD	09b0bc9e-3035-45b4-b61b-4aca70848360	6
311759	montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet	SY	23964723-2df8-4d0a-a53d-8538469672f1	6
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	23964723-2df8-4d0a-a53d-8538469672f1	6
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	09b0bc9e-3035-45b4-b61b-4aca70848360	6
242438	montelukast sodium 5 MG Chewable Tablet	PSN	c2d834e6-7b38-d266-e053-2995a90a27ef	2
242438	montelukast sodium 5 MG Chewable Tablet	PSN	f4c0b28f-283c-7e04-e053-2a95a90aa39c	2
242438	montelukast 5 MG Chewable Tablet	SCD	c2d834e6-7b38-d266-e053-2995a90a27ef	2
242438	montelukast 5 MG Chewable Tablet	SCD	f4c0b28f-283c-7e04-e053-2a95a90aa39c	2
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	c2d834e6-7b38-d266-e053-2995a90a27ef	2
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	f4c0b28f-283c-7e04-e053-2a95a90aa39c	2
242438	montelukast sodium 5 MG Chewable Tablet	PSN	1a312a28-8472-4cab-a7dd-d01cd8b2765a	1
242438	montelukast 5 MG Chewable Tablet	SCD	1a312a28-8472-4cab-a7dd-d01cd8b2765a	1
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	1a312a28-8472-4cab-a7dd-d01cd8b2765a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-728-10	31722072810	1000 TABLET, CHEWABLE in 1 BOTTLE (31722-728-10)	2015-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
montelukast sodium	A-S Medication Solutions	2026-03-07	HUMAN PRESCRIPTION DRUG LABEL	10
montelukast sodium	A-S Medication Solutions	2026-03-07	HUMAN PRESCRIPTION DRUG LABEL	1
montelukast sodium	Preferred Pharmaceuticals, Inc.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	6
MONTELUKAST SODIUM	DIRECT RX	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
montelukast sodium	Redpharn Drug, Inc \| Redpharm Drug, Inc	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
montelukast sodium	NuCare Pharmaceuticals,Inc.	2021-08-03	HUMAN PRESCRIPTION DRUG LABEL	1
montelukast sodium	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit V	2021-06-18	HUMAN PRESCRIPTION DRUG LABEL	6