Home NDC 69844-041 MONTELUKAST SODIUM
Product NDC 69844-041
11-digit product format 698440041
Labeler code 69844
Product ID 69844-041_3c5c6869-860e-48c3-aa92-cc6ff55d45e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MONTELUKAST SODIUM
Dosage form TABLET
Route ORAL
Labeler Graviti Pharmaceuticals Private Limited
Application ANDA209012
Marketing category ANDA
Marketing start 2020-04-06
Marketing end 0000-00-00
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 2021-12-31
Current FDA listing Historical FDA.report record 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 · 54 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 Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69844-041-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69844-041-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69844-041-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69844-041-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69844-041-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69844-041-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69844-041-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69844-041-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69844-041-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69844-041-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69844-041-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69844-041-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69844-041-02 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69844-041-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69844-041-02 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69844-041-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69844-041-02 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69844-041-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69844-041-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69844-041-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69844-041-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69844-041-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69844-041-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69844-041-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69844-041-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69844-041-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69844-041-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69844-041-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69844-041-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69844-041-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69844-041-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69844-041-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69844-041-02 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69844-041-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69844-041-02 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69844-041-01 I Inactivated by FDA bd6a592717d7…303034d00443…
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 A209012-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209012-001 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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69844-041-01 69844004101 30 TABLET in 1 BOTTLE (69844-041-01) 30 tablet 2020-04-06 0000-00-00 No No Current 69844-041-02 69844004102 90 TABLET in 1 BOTTLE (69844-041-02) 90 tablet 2020-04-06 0000-00-00 No No Current