Home NDC 68258-3032 SINGULAIR
Product NDC 68258-3032
11-digit product format 682583032
Labeler code 68258
Product ID 68258-3032_6f5962a5-487d-4d7d-a3eb-ec9d1e77caca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Dispensing Solutions Inc.
Application NDA020830
Marketing category NDA
Marketing start 2009-10-08
Marketing end 0000-00-00
Substance MONTELUKAST SODIUM
Active strength 5 mg/1
Pharmacologic classes Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68258-3032-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68258-3032-3 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68258-3032-3 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68258-3032-3 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68258-3032-3 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68258-3032-3 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68258-3032-3 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68258-3032-3 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68258-3032-3 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68258-3032-3 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68258-3032-3 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68258-3032-3 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68258-3032-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68258-3032-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68258-3032-3 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68258-3032-3 fb8cb913e6d1…eb8c232b6be0…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 68258-3032-3 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 68258-3032-3 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68258-3032-3 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68258-3032-3 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68258-3032-3 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68258-3032-3 110d247fa046…a55b01930146…
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.
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 68258-3032-3 SINGULAIR 30 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 MONTELUKAST ACTIVE MOIETY MHM278SD3E SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68258-3032 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.] 1 Legacy NDC, 1 package rows 20100303_10cd5ca5-6f8b-417c-af11-a2054a2dde34.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.
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): 020830 application number: NDA020830
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68258-3032-3 68258303203 30 in 1 BOTTLE, PLASTIC Historical