Home NDC 51128-503-03 MONTELUKAST
Product NDC 51128-503
Requested package NDC 51128-503-03
11-digit product format 511280503
Labeler code 51128
Product ID 51128-503_9eeede6e-480e-4b27-e053-2a95a90a34dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MONTELUKAST
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Recipharm Pharmaservices Private Limited
Application ANDA203037
Marketing category ANDA
Marketing start 2014-12-01
Marketing end 0000-00-00
Substance MONTELUKAST SODIUM
Active strength 5 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203037-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 A203037-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 51128-503-01 2020-02-19 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 51128-503-02 2020-02-19 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 51128-503-03 2020-02-19 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 51128-503-01 2020-01-31 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 51128-503-02 2020-01-31 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 51128-503-03 2020-01-31 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998
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 Marketing start Marketing end Sample Exclude flag Status 51128-503-03 51128050303 1000 TABLET, CHEWABLE in 1 BOTTLE (51128-503-03) 2014-12-01 0000-00-00 No No Current