Home NDC 59651-329 Montelukast Sodium
Product NDC 59651-329
11-digit product format 596510329
Labeler code 59651
Product ID 59651-329_2fcb1880-c88e-4c82-829e-6177a07814c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast Sodium
Dosage form GRANULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA213471
Marketing category ANDA
Marketing start 2020-02-18
Substance MONTELUKAST SODIUM
Active strength 4 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 A213471-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213471-001 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.
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 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213471-001 MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL AB 2020-02-18 a50c72e98297…
Observed Orange Book normalized TE history# 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 4 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 351246 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 59651-329-05 Montelukast Sodium 1 in 1 PACKET GRANULE 1 8 59651-329-30 Montelukast Sodium 30 in 1 CARTON GRANULE 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-329 MONTELUKAST SODIUM GRANULE [AUROBINDO PHARMA LIMITED] 8 Current NDC, Legacy NDC, 2 package rows 20230604_9a3bfc59-0ca6-4433-abf5-41659bfe0a8f.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 59651-329-05 59651032905 1 in 1 PACKET Historical 59651-329-30 59651032930 30 PACKET in 1 CARTON (59651-329-30) / 1 GRANULE in 1 PACKET (59651-329-05) 30 packet 2020-02-18 0000-00-00 No No Current