Home NDC 57237-255 Montelukast Sodium
Product NDC 57237-255
11-digit product format 572370255
Labeler code 57237
Product ID 57237-255_1da56873-29ff-4b62-bebb-123a87d0e042
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
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 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 RLD / RS 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.
Additional Listing Data#
Finished product Yes
Brand name base Montelukast Sodium
Listing expiration 2027-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57237-255-30 Montelukast Sodium 30 in 1 BOTTLE TABLET, FILM COATED 30 10 57237-255-90 Montelukast Sodium 90 in 1 BOTTLE TABLET, FILM COATED 90 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-255 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240406_49669ac0-0bb5-4576-bed5-9e85e0d76a44.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 ndc (product): 57237-255 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57237-255-30 57237025530 30 TABLET, FILM COATED in 1 BOTTLE (57237-255-30) 2012-08-03 0000-00-00 No No Current 57237-255-90 57237025590 90 TABLET, FILM COATED in 1 BOTTLE (57237-255-90) 2012-08-03 0000-00-00 No No Current