Home NDC 70518-4753 MONTELUKAST SODIUM
Product NDC 70518-4753
11-digit product format 705184753
Labeler code 70518
Product ID 70518-4753_5b85b9bc-921d-5ffd-e063-6394a90a965e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MONTELUKAST SODIUM
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA209012
Marketing category ANDA
Marketing start 2026-09-14
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 A209012-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209012-001 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 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209012-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2017-04-24 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
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4753-0 70518475300 90 TABLET in 1 BOTTLE, PLASTIC (70518-4753-0) 90 tablet 2026-09-14 No No Current