Home NDC 27241-017 MONTELUKAST SODIUM
Product NDC 27241-017
11-digit product format 272410017
Labeler code 27241
Product ID 27241-017_c7998daa-0220-4f57-a2b7-a2e468b10471
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MONTELUKAST
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA203328
Marketing category ANDA
Marketing start 2015-08-13
Substance MONTELUKAST SODIUM
Active strength 5 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 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 A203328-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 A203328-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31
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 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2015-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2015-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203328-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203328-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL 2015-07-31 782e0a99824c…
Observed Orange Book normalized TE history# 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 5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200224 Internal RxNorm lookup 242438 Internal RxNorm lookup 311759 Internal RxNorm lookup 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 27241-017-03 MONTELUKAST SODIUM 30 in 1 BOTTLE TABLET, CHEWABLE 30 20 27241-017-09 MONTELUKAST SODIUM 90 in 1 BOTTLE TABLET, CHEWABLE 90 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-017 MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA USA INC.] 19 Current NDC, Legacy NDC, 2 package rows 20211123_67070e4e-f755-46b3-b900-fcc1993a0546.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 · 3 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 27241-017-03 27241001703 30 TABLET, CHEWABLE in 1 BOTTLE (27241-017-03) 2015-08-13 0000-00-00 No No Current 27241-017-09 27241001709 90 TABLET, CHEWABLE in 1 BOTTLE (27241-017-09) 2015-08-13 0000-00-00 No No Current