Home NDC 59746-358 Montelukast sodium chewable
Product NDC 59746-358
11-digit product format 597460358
Labeler code 59746
Product ID 59746-358_758593f9-d960-4ac8-8ada-02aeae115244
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Jubilant Cadista Pharmaceuticals Inc.
Application ANDA203795
Marketing category ANDA
Marketing start 2015-02-28
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 96 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203795-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 A203795-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27
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 3 · 82 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 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203795-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203795-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-02-27 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded montelukast sodium ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 montelukast ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 aspartame INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 Hydroxypropyl Cellulose (type H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 mannitol INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1 Strawberry INACTIVE INGREDIENT 4J2TY8Y81V MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] 1