Home NDC 78206-170 SINGULAIR
Product NDC 78206-170
11-digit product format 782060170
Labeler code 78206
Product ID 78206-170_57a12189-3bb3-4a5d-b5fe-fc57db87c134
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Organon LLC
Application NDA020830
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020830-001 SINGULAIR MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 N020830-002 SINGULAIR MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL RLD 2000-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020830-001 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 3 · 82 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 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020830-001 SINGULAIR EQ 5MG BASE TABLET, CHEWABLE / ORAL AB RLD, RS 1998-02-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020830-002 SINGULAIR EQ 4MG BASE TABLET, CHEWABLE / ORAL AB RLD 2000-03-03 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
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 78206-170-01 SINGULAIR 30 in 1 BOTTLE TABLET, CHEWABLE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-170 SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [ORGANON LLC] 4 Current NDC, Legacy NDC, 1 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 Marketing start Marketing end Sample Exclude flag Status 78206-170-01 78206017001 30 TABLET, CHEWABLE in 1 BOTTLE (78206-170-01) 2021-06-01 0000-00-00 No No Current