Home NDC 13668-081 Montelukast Sodium
Product NDC 13668-081
11-digit product format 136680081
Labeler code 13668
Product ID 13668-081_64b8ff68-7440-43b9-bf2c-4e04e85b2a6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast Sodium
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA201515
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201515-001 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 A201515-001 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 A201515-001 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 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201515-001 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 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201515-001 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 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201515-001 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 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201515-001 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 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201515-001 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 A201515-001 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 A201515-001 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 A201515-001 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 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201515-001 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 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201515-001 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 A201515-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 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 · 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 13668-081-05 Montelukast Sodium 500 in 1 BOTTLE TABLET 500 23 13668-081-30 Montelukast Sodium 30 in 1 BOTTLE TABLET 30 23 13668-081-32 Montelukast Sodium 3200 in 1 BOTTLE TABLET 3200 23 13668-081-74 Montelukast Sodium 100 in 1 CARTON TABLET 100 23 13668-081-90 Montelukast Sodium 90 in 1 BOTTLE TABLET 90 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 CHERRY INACTIVE INGREDIENT BUC5I9595W MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED] 6 MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST SODIUM TABLET [PROFICIENT RX LP] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-081 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM GRANULE [TORRENT PHARMACEUTICALS LIMITED] 22 Current NDC, Legacy NDC, 5 package rows 20250529_da038cf6-cfad-43a4-ab8e-d81d028d6087.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 Units Marketing start Marketing end Sample Exclude flag Status 13668-081-05 13668008105 500 TABLET in 1 BOTTLE (13668-081-05) 500 tablet 2012-08-03 0000-00-00 No No Current 13668-081-30 13668008130 30 TABLET in 1 BOTTLE (13668-081-30) 30 tablet 2012-08-03 0000-00-00 No No Current 13668-081-32 13668008132 3200 TABLET in 1 BOTTLE (13668-081-32) 3200 tablet 2012-08-03 0000-00-00 No No Current 13668-081-74 13668008174 100 TABLET in 1 CARTON (13668-081-74) 100 tablet 2012-08-03 0000-00-00 No No Current 13668-081-90 13668008190 90 TABLET in 1 BOTTLE (13668-081-90) 90 tablet 2012-08-03 0000-00-00 No No Current