Home NDC 65162-732 Montelukast Sodium
Product NDC 65162-732
11-digit product format 651620732
Labeler code 65162
Product ID 65162-732_ce5720a0-a4c1-4532-8112-53201502c0eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA204604
Marketing category ANDA
Marketing start 2013-07-31
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 A204604-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204604-001 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 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 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 Sodium
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 65162-732-03 Montelukast Sodium 30 in 1 BOTTLE TABLET 30 18 65162-732-09 Montelukast Sodium 90 in 1 BOTTLE TABLET 90 18 65162-732-11 Montelukast Sodium 1000 in 1 BOTTLE TABLET 1000 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-732 MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS LLC] 15 Current NDC, Legacy NDC, 3 package rows 20241031_ccbbf0d6-efd9-4fdd-9e7b-e3d293062609.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 65162-732-03 65162073203 30 TABLET in 1 BOTTLE (65162-732-03) 30 tablet 2013-07-31 0000-00-00 No No Current 65162-732-09 65162073209 90 TABLET in 1 BOTTLE (65162-732-09) 90 tablet 2013-07-31 0000-00-00 No No Current 65162-732-11 65162073211 1000 TABLET in 1 BOTTLE (65162-732-11) 1000 tablet 2013-07-31 0000-00-00 No No Current