Home NDC 60723-010-03 Montelukast Sodium
Product NDC 60723-010
Requested package NDC 60723-010-03
11-digit product format 607230010
Labeler code 60723
Product ID 60723-010_a622c4f1-3ecc-eb59-e053-2995a90a8def
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast Sodium
Dosage form TABLET
Route ORAL
Labeler Hangzhou Minsheng Binjiang Pharm
Application ANDA205683
Marketing category ANDA
Marketing start 2016-05-30
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 · 18 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 A205683-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205683-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205683-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2016-01-12 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 60723-010-03 2022-01-28 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 60723-010-09 2022-01-28 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 60723-010-50 2022-01-28 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 60723-010-03 2020-06-02 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 60723-010-09 2020-06-02 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 60723-010-50 2020-06-02 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 60723-010-03 2020-01-31 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 60723-010-09 2020-01-31 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 60723-010-50 2020-01-31 These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60723-010-03 Montelukast Sodium 30 in 1 BOTTLE TABLET 30 3 60723-010-09 Montelukast Sodium 90 in 1 BOTTLE TABLET 90 3 60723-010-50 Montelukast Sodium 500 in 1 BOTTLE TABLET 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60723-010 MONTELUKAST SODIUM TABLET [HANGZHOU MINSHENG BINJIANG PHARM] 3 Legacy NDC, 3 package rows 20200527_7223644e-a5cc-498f-8cf4-7d3f20231389.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60723-010-03 60723001003 30 TABLET in 1 BOTTLE (60723-010-03) 30 tablet 2021-05-31 0000-00-00 No No Current