Home NDC 68071-5278 montelukast sodium
Product NDC 68071-5278
11-digit product format 680715278
Labeler code 68071
Product ID 68071-5278_2a80536c-27fd-0142-e063-6294a90a458f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA204290
Marketing category ANDA
Marketing start 2016-01-01
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68071-5278-3 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68071-5278-3 bd6a592717d7…303034d00443…
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 A204290-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204290-001 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 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204290-001 MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB 2015-10-08 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 · 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-5278-3 montelukast sodium 30 in 1 BOTTLE TABLET, FILM COATED 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-5278 MONTELUKAST SODIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250101_a7c11cbe-0834-27a5-e053-2995a90ac43f.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join montelukast sodium MONTELUKAST SODIUM Preferred Pharmaceuticals Inc. 1eeb3123-9e93-4681-8096-800a7c7acf8a 2026-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290 montelukast sodium MONTELUKAST SODIUM NuCare Pharmaceuticals,Inc. a7c11cbe-0834-27a5-e053-2995a90ac43f 2024-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290 ndc (product): 68071-5278 montelukast sodium MONTELUKAST SODIUM Bryant Ranch Prepack 9beb1510-f3af-4269-a9d0-e2bd41ac369b 2024-04-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290 montelukast sodium MONTELUKAST SODIUM Unichem Pharmaceuticals (USA), Inc. 9e375c07-70db-458c-9336-22a7037b0a5f 2023-06-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290 montelukast sodium MONTELUKAST SODIUM Proficient Rx LP 2ce48faf-4504-488a-8b20-3e8d4f008fb2 2022-06-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204290 application number: ANDA204290
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 68071-5278-3 68071527803 30 TABLET, FILM COATED in 1 BOTTLE (68071-5278-3) 2020-06-10 0000-00-00 No No Current