Home NDC 0781-5560 Montelukast
Product NDC 0781-5560
11-digit product format 007815560
Labeler code 0781
Product ID 0781-5560_e593fadb-cac5-44ca-8fd6-93c626cd40a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA200889
Marketing category ANDA
Marketing start 2012-08-03
Substance MONTELUKAST SODIUM
Active strength 10 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 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 · 40 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200889-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200889-001 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.
Product history page 1 of 2 · 41 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 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL 2012-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200889-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Montelukast
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MONTELUKAST SODIUM 10 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 200224 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 0781-5560-06 Montelukast 10 in 1 BLISTER PACK TABLET, FILM COATED 10 15 0781-5560-13 Montelukast 10 in 1 CARTON TABLET, FILM COATED 10 15 0781-5560-31 Montelukast 30 in 1 BOTTLE TABLET, FILM COATED 30 15 0781-5560-92 Montelukast 90 in 1 BOTTLE TABLET, FILM COATED 90 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 SUCROSE INACTIVE INGREDIENT C151H8M554 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC] 7
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 0781-5560-06 00781556006 10 in 1 BLISTER PACK Historical 0781-5560-13 00781556013 10 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06) 10 blister pack 2025-06-13 0000-00-00 No No Current 0781-5560-31 00781556031 30 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31) 2025-06-13 0000-00-00 No No Current 0781-5560-92 00781556092 90 TABLET, FILM COATED in 1 BOTTLE (0781-5560-92) 2025-06-13 0000-00-00 No No Current