Home NDC 0006-9117 SINGULAIR
Product NDC 0006-9117
11-digit product format 000069117
Labeler code 0006
Product ID 0006-9117_582e9110-dc03-48f5-a4b8-693cd5cdbf10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme Corp.
Application NDA020829
Marketing category NDA
Marketing start 1998-02-20
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 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 N020829-002 SINGULAIR EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-02-20 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded montelukast sodium ACTIVE INGREDIENT U1O3J18SFL SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 montelukast ACTIVE MOIETY MHM278SD3E SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 aspartame INACTIVE INGREDIENT Z0H242BBR1 SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 hydroxypropyl cellulose (type h) INACTIVE INGREDIENT RFW2ET671P SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 mannitol INACTIVE INGREDIENT 3OWL53L36A SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 48
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SINGULAIR MONTELUKAST SODIUM Organon LLC 482dcc92-b47f-4ea6-854a-f5ac2aea7842 2025-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020829 application number: NDA020829
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0006-9117-31 00006911731 30 TABLET, FILM COATED in 1 BOTTLE (0006-9117-31) 1998-02-20 0000-00-00 No No Current 0006-9117-54 00006911754 90 TABLET, FILM COATED in 1 BOTTLE (0006-9117-54) 1998-02-20 0000-00-00 No No Current