Home NDC 33342-102 Montelukast
Product NDC 33342-102
11-digit product format 333420102
Labeler code 33342
Product ID 33342-102_c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA203366
Marketing category ANDA
Marketing start 2014-09-11
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 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 A203366-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203366-001 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 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203366-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2014-09-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Montelukast
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200224 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 33342-102-07 Montelukast 30 in 1 BOTTLE TABLET 30 11 33342-102-10 Montelukast 90 in 1 BOTTLE TABLET 90 11 33342-102-12 Montelukast 100 in 1 BLISTER PACK TABLET 100 11 33342-102-15 Montelukast 500 in 1 BOTTLE TABLET 500 11 33342-102-39 Montelukast 90 in 1 BLISTER PACK TABLET 90 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-102 MONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED] 11 Current NDC, Legacy NDC, 5 package rows 20230217_e0c5b856-3f70-4ca6-9763-a90673bb82fb.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Montelukast MONTELUKAST Coupler LLC 583a9499-97f0-2ebf-e063-6394a90a35af 2026-08-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203366 application number: ANDA203366 Montelukast MONTELUKAST NuCare Pharmaceuticals, Inc. 365e1c5c-01b2-bf4e-e063-6394a90a0e43 2025-05-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203366 application number: ANDA203366 Montelukast MONTELUKAST NuCare Pharmaceuticals,Inc. 56429f04-97b6-06a9-e054-00144ff88e88 2024-07-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 203366 application number: ANDA203366 Montelukast MONTELUKAST Macleods Pharmaceuticals Limited e0c5b856-3f70-4ca6-9763-a90673bb82fb 2023-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203366 application number: ANDA203366 ndc (product): 33342-102 Montelukast MONTELUKAST BluePoint Laboratories 4c411d3e-47b6-481b-b846-419ed4cbb947 2022-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203366 application number: ANDA203366
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 33342-102-07 33342010207 30 TABLET in 1 BOTTLE (33342-102-07) 30 tablet 2014-09-11 0000-00-00 No No Current 33342-102-10 33342010210 90 TABLET in 1 BOTTLE (33342-102-10) 90 tablet 2014-09-11 0000-00-00 No No Current 33342-102-12 33342010212 100 TABLET in 1 BLISTER PACK (33342-102-12) 100 tablet 2014-09-11 0000-00-00 No No Current 33342-102-15 33342010215 500 TABLET in 1 BOTTLE (33342-102-15) 500 tablet 2014-09-11 0000-00-00 No No Current 33342-102-39 33342010239 90 TABLET in 1 BLISTER PACK (33342-102-39) 90 tablet 2014-09-11 0000-00-00 No No Current