Home Applications 020829 Application 020829
Type NDA
Sponsor MSD MERCK CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 SINGULAIR MONTELUKAST SODIUM TABLET;ORAL EQ 10MG BASE Yes 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 N020829-002 SINGULAIR MONTELUKAST SODIUM EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020829-002 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 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-9117 SINGULAIR montelukast sodium Merck Sharp & Dohme Corp. NDA Current 0006-9117 SINGULAIR montelukast sodium Merck Sharp & Dohme Corp. NDA Current 0006-9117 SINGULAIR montelukast sodium Merck Sharp & Dohme Corp. NDA Current 0006-9117 SINGULAIR montelukast sodium Merck Sharp & Dohme Corp. NDA Current 21695-221 SINGULAIR montelukast sodium Rebel Distributors Corp NDA Current 68258-3033 SINGULAIR montelukast sodium Dispensing Solutions Inc. NDA Current 78206-172 SINGULAIR montelukast sodium Organon LLC NDA Current 78206-172 SINGULAIR montelukast sodium Organon LLC NDA Current