Home NDC 65162-732 Montelukast Sodium
Product NDC 65162-732
11-digit product format 651620732
Labeler code 65162
Product ID 65162-732_c2e9ec7d-8998-4a92-8394-5da85fb91fcf
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204604-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-09-04 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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