Home NDC 55111-725-94 Montelukast Sodium
Product NDC 55111-725
Requested package NDC 55111-725-94
11-digit product format 551110725
Labeler code 55111
Product ID 55111-725_8bc013e8-5324-099d-e603-d78012b126bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Montelukast Sodium
Dosage form TABLET, COATED
Route ORAL
Labeler Dr.Reddy's Laboratories Limited
Application ANDA201582
Marketing category ANDA
Marketing start 2012-08-06
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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A201582-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201582-001 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 · 42 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 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201582-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2012-08-06 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200224 Internal RxNorm lookup 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 55111-725-01 Montelukast Sodium 100 in 1 BOTTLE TABLET, COATED 100 24 55111-725-10 Montelukast Sodium 1000 in 1 BOTTLE TABLET, COATED 1000 24 55111-725-30 Montelukast Sodium 30 in 1 BOTTLE TABLET, COATED 30 24 55111-725-78 Montelukast Sodium 10 in 1 CARTON TABLET, COATED 10 24 55111-725-79 Montelukast Sodium 10 in 1 BLISTER PACK TABLET, COATED 10 24 55111-725-90 Montelukast Sodium 90 in 1 BOTTLE TABLET, COATED 90 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Montelukast Sodium ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 montelukast ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 aspartame INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 cherry INACTIVE INGREDIENT BUC5I9595W MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 Hydroxypropyl Cellulose (Type H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 17 Montelukast Sodium ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 montelukast ACTIVE MOIETY MHM278SD3E MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 aspartame INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 cherry INACTIVE INGREDIENT BUC5I9595W MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 Hydroxypropyl Cellulose (Type H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-725 MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] 24 Current NDC, Legacy NDC, 6 package rows 20221217_3d4451a9-d73d-b9de-68ec-853bfeff6e4b.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 55111-725-94 55111072594 4000 TABLET, COATED in 1 POUCH (55111-725-94) 20-JUN-13 Current