Home NDC 0603-4653 Montelukast Sodium
Product NDC 0603-4653
11-digit product format 006034653
Labeler code 0603
Product ID 0603-4653_ab3aeb32-71f3-4b01-b964-83065fed74f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Par Pharmaceutical
Application ANDA091588
Marketing category ANDA
Marketing start 2012-08-03
Marketing end 2020-01-31
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 0000-00-00
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 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A091588-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 A091588-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03
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 · 84 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 2026-08-18 06:07:40 2026-07 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091588-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091588-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2012-08-03 bb7c543d1eb4…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS] 20