Montelukast Sodium

Product NDC: 16729-119
Requested package NDC: 16729-119-10
11-digit product format: 167290119
Labeler code: 16729
Product ID: 16729-119_d481e75b-ffed-a218-e053-2995a90a19c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA202717
Marketing category: ANDA
Marketing start: 2013-04-11
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: 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 · 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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202717-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202717-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Montelukast Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MONTELUKAST SODIUM	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U1O3J18SFL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200224	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
6eea668f-a2fa-447f-b2d5-4c754d13d9fa	Available on FDA.report

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
16729-119-10	Montelukast Sodium	30 in 1 BOTTLE	TABLET, FILM COATED	30	15
16729-119-15	Montelukast Sodium	90 in 1 BOTTLE	TABLET, FILM COATED	90	15
16729-119-17	Montelukast Sodium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-119-10	EA - Each	16729-119	4a1db3a1-c7f7-4314-87fe-e4cfa503ddde	1	2013-05-02
16729-119-15	EA - Each	16729-119	3cf8c7d4-068d-4686-8cff-6f1a5d5c9b34	1	2013-05-02
16729-119-17	EA - Each	16729-119	5561596e-d56f-4965-a47a-e9de33c82820	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	6
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-119	MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	15	Current NDC, Legacy NDC, 3 package rows	20220102_6eea668f-a2fa-447f-b2d5-4c754d13d9fa.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 ndc (package): 16729-119-10 ndc (product): 16729-119 ndc11 (package): 16729011910

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	c9ec1996-6a54-4622-b8a6-57dea49f6b35	22
200224	montelukast 10 MG Oral Tablet	SCD	c9ec1996-6a54-4622-b8a6-57dea49f6b35	22
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	c9ec1996-6a54-4622-b8a6-57dea49f6b35	22
200224	montelukast sodium 10 MG Oral Tablet	PSN	6eea668f-a2fa-447f-b2d5-4c754d13d9fa	15
200224	montelukast 10 MG Oral Tablet	SCD	6eea668f-a2fa-447f-b2d5-4c754d13d9fa	15
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	6eea668f-a2fa-447f-b2d5-4c754d13d9fa	15
200224	montelukast sodium 10 MG Oral Tablet	PSN	4ba27278-6249-4546-9331-b19302cbf2db	8
200224	montelukast 10 MG Oral Tablet	SCD	4ba27278-6249-4546-9331-b19302cbf2db	8
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	4ba27278-6249-4546-9331-b19302cbf2db	8
200224	montelukast sodium 10 MG Oral Tablet	PSN	97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5	6
200224	montelukast 10 MG Oral Tablet	SCD	97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5	6
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5	6
200224	montelukast sodium 10 MG Oral Tablet	PSN	fdc5e630-3a01-4db6-8107-0e220dca2ba1	5
200224	montelukast sodium 10 MG Oral Tablet	PSN	549f1d1a-81f5-29f5-e054-00144ff8d46c	5
200224	montelukast 10 MG Oral Tablet	SCD	549f1d1a-81f5-29f5-e054-00144ff8d46c	5
200224	montelukast 10 MG Oral Tablet	SCD	fdc5e630-3a01-4db6-8107-0e220dca2ba1	5
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	549f1d1a-81f5-29f5-e054-00144ff8d46c	5
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	fdc5e630-3a01-4db6-8107-0e220dca2ba1	5
200224	montelukast sodium 10 MG Oral Tablet	PSN	566a8fd7-fc00-2297-e054-00144ff8d46c	4
200224	montelukast sodium 10 MG Oral Tablet	PSN	2de887d6-93b8-4309-a12d-d08d8b1ed552	4
200224	montelukast 10 MG Oral Tablet	SCD	566a8fd7-fc00-2297-e054-00144ff8d46c	4
200224	montelukast 10 MG Oral Tablet	SCD	2de887d6-93b8-4309-a12d-d08d8b1ed552	4
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	566a8fd7-fc00-2297-e054-00144ff8d46c	4
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	2de887d6-93b8-4309-a12d-d08d8b1ed552	4
200224	montelukast sodium 10 MG Oral Tablet	PSN	2fbdf1be-a37f-879b-e063-6394a90aa20d	3
200224	montelukast 10 MG Oral Tablet	SCD	2fbdf1be-a37f-879b-e063-6394a90aa20d	3
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	2fbdf1be-a37f-879b-e063-6394a90aa20d	3
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
16729-119-10	16729011910	30 TABLET, FILM COATED in 1 BOTTLE (16729-119-10)	2013-06-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Montelukast Sodium	Redpharm Drug	2025-12-30	HUMAN PRESCRIPTION DRUG LABEL	3
Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	22
Montelukast Sodium	Preferred Pharmaceuticals Inc.	2024-07-22	HUMAN PRESCRIPTION DRUG LABEL	9
Montelukast Sodium	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
Montelukast Sodium	NuCare Pharmaceuticals,Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	5
Montelukast Sodium	A-S Medication Solutions	2024-05-29	HUMAN PRESCRIPTION DRUG LABEL	18
Montelukast Sodium	A-S Medication Solutions	2024-05-29	HUMAN PRESCRIPTION DRUG LABEL	9
Montelukast Sodium	Bryant Ranch Prepack	2023-11-01	HUMAN PRESCRIPTION DRUG LABEL	8
Montelukast Sodium	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Montelukast Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL	4
MONTELUKAST SODIUM	DIRECT RX	2023-01-11	HUMAN PRESCRIPTION DRUG LABEL	4
Montelukast Sodium	REMEDYREPACK INC.	2022-05-19	HUMAN PRESCRIPTION DRUG LABEL	11
Montelukast Sodium	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	6
Montelukast Sodium	Bryant Ranch Prepack	2022-02-14	HUMAN PRESCRIPTION DRUG LABEL	2
Montelukast Sodium	Accord Healthcare Inc. \| Intas Pharmaceuticals Ltd \| Intas Pharmaceuticals Limited	2022-01-01	HUMAN PRESCRIPTION DRUG LABEL	15
Montelukast Sodium	Bryant Ranch Prepack	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	2
Montelukast Sodium	REMEDYREPACK INC.	2019-03-11	HUMAN PRESCRIPTION DRUG LABEL	4