Home NDC 78206-171 SINGULAIR
Product NDC 78206-171
11-digit product format 782060171
Labeler code 78206
Product ID 78206-171_57a12189-3bb3-4a5d-b5fe-fc57db87c134
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form GRANULE
Route ORAL
Labeler Organon LLC
Application NDA021409
Marketing category NDA
Marketing start 2021-06-01
Substance MONTELUKAST SODIUM
Active strength 4 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 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 N021409-001 SINGULAIR MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE / ORAL RLD 2002-07-26
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 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL RLD 2002-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021409-001 SINGULAIR EQ 4MG BASE/PACKET GRANULE / ORAL AB RLD, RS 2002-07-26 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 ea99ee380514…2023-01-26 05:58 UTC 2023-01 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021409-001 8007830 2022-10-24 Drug product 2011-09-29 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base SINGULAIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MONTELUKAST SODIUM 4 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153892 Internal RxNorm lookup 153893 Internal RxNorm lookup 200224 Internal RxNorm lookup 242438 Internal RxNorm lookup 261367 Internal RxNorm lookup 311759 Internal RxNorm lookup 351246 Internal RxNorm lookup 404406 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 78206-171-01 SINGULAIR 1 in 1 PACKET GRANULE 1 5 78206-171-01 SINGULAIR 30 in 1 CARTON GRANULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-171 SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [ORGANON LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241017_482dcc92-b47f-4ea6-854a-f5ac2aea7842.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 · 1 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 78206-171-01 78206017101 30 PACKET in 1 CARTON (78206-171-01) / 1 GRANULE in 1 PACKET 30 packet 2021-06-01 0000-00-00 No No Current