Home NDC 33342-110 Montelukast sodium
Product NDC 33342-110
11-digit product format 333420110
Labeler code 33342
Product ID 33342-110_a12af8c6-41af-4850-b725-4f8226b35b67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast sodium
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA203582
Marketing category ANDA
Marketing start 2015-03-13
Substance MONTELUKAST
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 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 A203582-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 A203582-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203582-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203582-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-03-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Montelukast sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MONTELUKAST 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MHM278SD3E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242438 Internal RxNorm lookup 311759 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 33342-110-07 Montelukast sodium 30 in 1 BOTTLE TABLET, CHEWABLE 30 8 33342-110-10 Montelukast sodium 90 in 1 BOTTLE TABLET, CHEWABLE 90 8 33342-110-12 Montelukast sodium 100 in 1 BLISTER PACK TABLET, CHEWABLE 100 8 33342-110-15 Montelukast sodium 500 in 1 BOTTLE TABLET, CHEWABLE 500 8 33342-110-39 Montelukast sodium 90 in 1 BLISTER PACK TABLET, CHEWABLE 90 8 33342-110-44 Montelukast sodium 1000 in 1 BOTTLE TABLET, CHEWABLE 1000 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST ACTIVE INGREDIENT MHM278SD3E MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 CHERRY INACTIVE INGREDIENT BUC5I9595W MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-110 MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED] 8 Current NDC, Legacy NDC, 6 package rows 20230917_ce512844-5220-4661-809f-56d088699c9c.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 Marketing start Marketing end Sample Exclude flag Status 33342-110-07 33342011007 30 TABLET, CHEWABLE in 1 BOTTLE (33342-110-07) 2015-03-13 0000-00-00 No No Current 33342-110-10 33342011010 90 TABLET, CHEWABLE in 1 BOTTLE (33342-110-10) 2015-03-13 0000-00-00 No No Current 33342-110-12 33342011012 100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-110-12) 2015-03-13 0000-00-00 No No Current 33342-110-15 33342011015 500 TABLET, CHEWABLE in 1 BOTTLE (33342-110-15) 2015-03-13 0000-00-00 No No Current 33342-110-39 33342011039 90 TABLET, CHEWABLE in 1 BLISTER PACK (33342-110-39) 2015-03-13 0000-00-00 No No Current 33342-110-44 33342011044 1000 TABLET, CHEWABLE in 1 BOTTLE (33342-110-44) 2015-09-25 0000-00-00 No No Current