Montelukast Sodium

Product NDC: 65862-574
11-digit product format: 658620574
Labeler code: 65862
Product ID: 65862-574_035c2d56-5707-4d1e-96b8-7c9c2e848bb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA202468
Marketing category: ANDA
Marketing start: 2012-08-03
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

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	65862-574		UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	65862-574	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	2026-08-17
excluded product	product	65862-574		D	Discontinued by firm	2026-08-17
excluded package	package	65862-574	65862-574-10	D	Discontinued by firm	2026-08-17
excluded package	package	65862-574	65862-574-19	D	Discontinued by firm	2026-08-17
excluded package	package	65862-574	65862-574-30	D	Discontinued by firm	2026-08-17
excluded package	package	65862-574	65862-574-90	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 2 · 102 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-574-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-574-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-574-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-574-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-574-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-574-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-574-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-574-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-574-35	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-574-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-574-19	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-574-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A202468-001	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
A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202468-001	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	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202468-001	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202468-001	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	A202468-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202468-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202468-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202468-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202468-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202468-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202468-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202468-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202468-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202468-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202468-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202468-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202468-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202468-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202468-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202468-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202468-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202468-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202468-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202468-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202468-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202468-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202468-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202468-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202468-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202468-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202468-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202468-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202468-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202468-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202468-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202468-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202468-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202468-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202468-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202468-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202468-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202468-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202468-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202468-001	AB	1	`e64feba35796…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200224	Internal RxNorm lookup
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
ba42b0a9-83f1-4283-a853-f99cdd0761b9	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
65862-574-10	Montelukast Sodium	10 in 1 CARTON	TABLET, FILM COATED	10	21
65862-574-10	Montelukast Sodium	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	21
65862-574-19	Montelukast Sodium	10000 in 1 BOTTLE	TABLET, FILM COATED	10000	21
65862-574-30	Montelukast Sodium	30 in 1 BOTTLE	TABLET, FILM COATED	30	21
65862-574-90	Montelukast Sodium	90 in 1 BOTTLE	TABLET, FILM COATED	90	21
65862-574-10	Montelukast Sodium	10 in 1 CARTON	TABLET, FILM COATED	10	6
65862-574-10	Montelukast Sodium	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	6
65862-574-19	Montelukast Sodium	10000 in 1 BOTTLE	TABLET, FILM COATED	10000	6
65862-574-30	Montelukast Sodium	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
65862-574-90	Montelukast Sodium	90 in 1 BOTTLE	TABLET, FILM COATED	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-574-19	EA - Each	65862-574	55ab9f93-3726-4f87-832c-f9368b78db4f	1	2013-02-13
65862-574-30	EA - Each	65862-574	8950794b-c106-4158-a99a-e1b0d3285389	1	2013-02-13
65862-574-90	EA - Each	65862-574	bba34d68-6dc3-4fc0-80fc-5bfc683301a1	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
MONTELUKAST SODIUM	ACTIVE INGREDIENT	U1O3J18SFL	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
MONTELUKAST	ACTIVE MOIETY	MHM278SD3E	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-574	MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	21	Current NDC, Legacy NDC, 5 package rows	20240403_ba42b0a9-83f1-4283-a853-f99cdd0761b9.zip
65862-574	MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	6	Current NDC, Legacy NDC, 5 package rows	20141231_7636a692-558f-4649-86d9-b6699c3eeca1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast Sodium	MONTELUKAST SODIUM	Rising Pharma Holdings, Inc.	49669ac0-0bb5-4576-bed5-9e85e0d76a44	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202468 application number: ANDA202468
Montelukast Sodium	MONTELUKAST SODIUM	PD-Rx Pharmaceuticals, Inc.	6ffff72c-8784-477b-8722-5434a19881a0	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202468 application number: ANDA202468
Montelukast Sodium	MONTELUKAST SODIUM	Aurobindo Pharma Limited	ba42b0a9-83f1-4283-a853-f99cdd0761b9	2024-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202468 application number: ANDA202468 ndc (product): 65862-574
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	461f2aaa-e091-478e-97c1-27a089db8cdc	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202468 application number: ANDA202468

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	6ffff72c-8784-477b-8722-5434a19881a0	24
200224	montelukast 10 MG Oral Tablet	SCD	6ffff72c-8784-477b-8722-5434a19881a0	24
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	6ffff72c-8784-477b-8722-5434a19881a0	24
200224	montelukast sodium 10 MG Oral Tablet	PSN	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
311759	montelukast sodium 4 MG Chewable Tablet	PSN	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
242438	montelukast sodium 5 MG Chewable Tablet	PSN	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
200224	montelukast 10 MG Oral Tablet	SCD	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
311759	montelukast 4 MG Chewable Tablet	SCD	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
242438	montelukast 5 MG Chewable Tablet	SCD	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
311759	montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable Tablet	SY	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
242438	montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet	SY	ba42b0a9-83f1-4283-a853-f99cdd0761b9	21
200224	montelukast sodium 10 MG Oral Tablet	PSN	7636a692-558f-4649-86d9-b6699c3eeca1	6
200224	montelukast 10 MG Oral Tablet	SCD	7636a692-558f-4649-86d9-b6699c3eeca1	6
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	7636a692-558f-4649-86d9-b6699c3eeca1	6
200224	montelukast sodium 10 MG Oral Tablet	PSN	b83e509b-f6fd-4d11-adef-516999b2701c	5
200224	montelukast 10 MG Oral Tablet	SCD	b83e509b-f6fd-4d11-adef-516999b2701c	5
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	b83e509b-f6fd-4d11-adef-516999b2701c	5
200224	montelukast sodium 10 MG Oral Tablet	PSN	46b85c12-52bc-4768-a7c8-40b1546e9e0e	1
200224	montelukast sodium 10 MG Oral Tablet	PSN	461f2aaa-e091-478e-97c1-27a089db8cdc	1
200224	montelukast 10 MG Oral Tablet	SCD	461f2aaa-e091-478e-97c1-27a089db8cdc	1
200224	montelukast 10 MG Oral Tablet	SCD	46b85c12-52bc-4768-a7c8-40b1546e9e0e	1
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	46b85c12-52bc-4768-a7c8-40b1546e9e0e	1
200224	montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet	SY	461f2aaa-e091-478e-97c1-27a089db8cdc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-574-10	65862057410	10 BLISTER PACK in 1 CARTON (65862-574-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2012-08-03	0000-00-00	No	No	Current
65862-574-19	65862057419	10000 TABLET, FILM COATED in 1 BOTTLE (65862-574-19)		2012-08-03	0000-00-00	No	No	Current
65862-574-30	65862057430	30 TABLET, FILM COATED in 1 BOTTLE (65862-574-30)		2012-08-03	0000-00-00	No	No	Current
65862-574-35	65862057435	3500 TABLET, FILM COATED in 1 BAG (65862-574-35)		03-AUG-12				Current
65862-574-90	65862057490	90 TABLET, FILM COATED in 1 BOTTLE (65862-574-90)		2012-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Montelukast Sodium	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	24
Montelukast Sodium	Aurobindo Pharma Limited \| Aurolife Pharma LLC	2024-03-30	Human Prescription Drug Label	21
Montelukast Sodium	RPK Pharmaceuticals, Inc.	2023-10-25	Human Prescription Drug Label	5
Montelukast Sodium	Proficient Rx LP	2023-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
Montelukast Sodium	Aphena Pharma Solutions - Tennessee, LLC	2018-09-11	Human Prescription Drug Label	1
Montelukast Sodium	Aurobindo Pharma Limited	2014-12-24	Human Prescription Drug Label	6