Home NDC 63629-2979 SINGULAIR
Product NDC 63629-2979
11-digit product format 636292979
Labeler code 63629
Product ID 63629-2979_ab8e2247-7a40-45d7-9ef9-e6fe64433f40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name montelukast sodium
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA020830
Marketing category NDA
Marketing start 1998-02-20
Marketing end 0000-00-00
Substance MONTELUKAST SODIUM
Active strength 4 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-2979-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63629-2979-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63629-2979-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63629-2979-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63629-2979-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63629-2979-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63629-2979-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63629-2979-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63629-2979-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63629-2979-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63629-2979-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63629-2979-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63629-2979-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-2979-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63629-2979-1 I Inactivated by FDA 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.
FDA-Initiated Inactive NDC Indexing# 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 [BRYANT RANCH PREPACK] 1000 MONTELUKAST ACTIVE MOIETY MHM278SD3E SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] 1000 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] 1000 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] 1000 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] 1000 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] 1000 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK] 1000
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