Montelukast Sodium

Product NDC: 0093-7426
11-digit product format: 000937426
Labeler code: 0093
Product ID: 0093-7426_7d53adbd-8c7e-4e6b-b310-353dd087fac3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA078605
Marketing category: ANDA
Marketing start: 2012-08-03
Marketing end: 2021-09-30
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: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0093-7426		D	Discontinued by firm	2026-08-17
excluded package	package	0093-7426	0093-7426-10	D	Discontinued by firm	2026-08-17
excluded package	package	0093-7426	0093-7426-56	D	Discontinued by firm	2026-08-17
excluded package	package	0093-7426	0093-7426-98	D	Discontinued by firm	2026-08-17

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-7426-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-7426-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-7426-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-7426-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-7426-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-7426-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-7426-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-7426-98	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-7426-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-7426-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-7426-98	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-7426-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-7426-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-7426-98	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-7426-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-7426-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-7426-98	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-7426-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-7426-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-7426-98	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-7426-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-7426-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-7426-98	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-7426-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-7426-56	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-7426-98	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-7426-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-7426-56	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-7426-98	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-7426-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-7426-56	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-7426-98	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-7426-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-7426-56	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-7426-98	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-7426-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078605-001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB		2012-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078605-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078605-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078605-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078605-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078605-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078605-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078605-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078605-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078605-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078605-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078605-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078605-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078605-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078605-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078605-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078605-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078605-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078605-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078605-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078605-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078605-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078605-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078605-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078605-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078605-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078605-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078605-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078605-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078605-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078605-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078605-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078605-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078605-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078605-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078605-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078605-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078605-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078605-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078605-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078605-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078605-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078605-001	AB	1	`e64feba35796…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7426-10	EA - Each	0093-7426	696aa873-d8a2-4bec-a945-8c421f73a323	1	2013-02-13
0093-7426-56	EA - Each	0093-7426	1f3bae87-05b1-4fb2-8dee-9b5385958ed3	1	2013-02-13
0093-7426-98	EA - Each	0093-7426	bbfae67b-a86e-422a-ba01-e298d943a267	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]	9
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	7
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]	2
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

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	bfa9d526-6c07-4391-96a7-e8c6d6e4b573	14
200224	montelukast 10 MG Oral Tablet	SCD	bfa9d526-6c07-4391-96a7-e8c6d6e4b573	14
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	bfa9d526-6c07-4391-96a7-e8c6d6e4b573	14
200224	montelukast sodium 10 MG Oral Tablet	PSN	09692f56-468c-4884-ae95-d2fb9d984e4c	2
311759	montelukast sodium 4 MG Chewable Tablet	PSN	09692f56-468c-4884-ae95-d2fb9d984e4c	2
242438	montelukast sodium 5 MG Chewable Tablet	PSN	09692f56-468c-4884-ae95-d2fb9d984e4c	2
200224	montelukast 10 MG Oral Tablet	SCD	09692f56-468c-4884-ae95-d2fb9d984e4c	2
311759	montelukast 4 MG Chewable Tablet	SCD	09692f56-468c-4884-ae95-d2fb9d984e4c	2
242438	montelukast 5 MG Chewable Tablet	SCD	09692f56-468c-4884-ae95-d2fb9d984e4c	2
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	09692f56-468c-4884-ae95-d2fb9d984e4c	2
311759	montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet	SY	09692f56-468c-4884-ae95-d2fb9d984e4c	2
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	09692f56-468c-4884-ae95-d2fb9d984e4c	2
200224	montelukast sodium 10 MG Oral Tablet	PSN	b24549cf-6c14-4e49-8756-5bd6d88ec6b8	1
200224	montelukast 10 MG Oral Tablet	SCD	b24549cf-6c14-4e49-8756-5bd6d88ec6b8	1
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	b24549cf-6c14-4e49-8756-5bd6d88ec6b8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-7426-10	00093742610	1000 TABLET, FILM COATED in 1 BOTTLE (0093-7426-10)	2012-08-03	2021-06-30	No	No	Current
0093-7426-56	00093742656	30 TABLET, FILM COATED in 1 BOTTLE (0093-7426-56)	2012-08-03	2021-04-30	No	No	Current
0093-7426-98	00093742698	90 TABLET, FILM COATED in 1 BOTTLE (0093-7426-98)	2012-08-03	2021-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Montelukast Sodium	QPharma Inc \| Teva Pharmaceuticals USA, Inc. \| Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-03-03	HUMAN PRESCRIPTION DRUG LABEL	4
Montelukast Sodium	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	2020-07-31	HUMAN PRESCRIPTION DRUG LABEL	18
Montelukast Sodium	REMEDYREPACK INC.	2019-06-07	HUMAN PRESCRIPTION DRUG LABEL	3
Montelukast	International Laboratories, LLC	2017-06-09	HUMAN PRESCRIPTION DRUG LABEL	14
Montelukast Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	2014-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
Montelukast Sodium	MedVantx, Inc. \| Teva Pharmaceuticals USA Inc \| Blenheim Pharmacal, Inc.	2012-12-28	HUMAN PRESCRIPTION DRUG LABEL	1
Montelukast Sodium	Physicians Total Care, Inc.	2012-09-14	HUMAN PRESCRIPTION DRUG LABEL	2