Home NDC 69452-107 MONTELUKAST
Product NDC 69452-107
11-digit product format 694520107
Labeler code 69452
Product ID 69452-107_d44af51c-2284-0c9a-e053-2995a90a7bcd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MONTELUKAST
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Bionpharma Inc.
Application ANDA203037
Marketing category ANDA
Marketing start 2014-12-01
Marketing end 2021-12-31
Substance MONTELUKAST SODIUM
Active strength 5 mg/1
Pharmacologic classes Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 52 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 69452-107-13 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69452-107-19 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69452-107-19 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69452-107-19 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69452-107-19 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69452-107-19 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69452-107-19 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69452-107-19 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69452-107-19 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69452-107-19 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69452-107-19 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69452-107-19 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69452-107-32 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 69452-107-13 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69452-107-19 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69452-107-32 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 69452-107-32 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 69452-107-13 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 69452-107-19 E Excluded after deficient or non-compliant submission was not corrected 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 A203037-001 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 A203037-002 MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203037-001 MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203037-002 MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE / ORAL AB 2014-10-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MONTELUKAST SODIUM ACTIVE INGREDIENT U1O3J18SFL MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 MONTELUKAST ACTIVE MOIETY MHM278SD3E MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 CHERRY INACTIVE INGREDIENT BUC5I9595W MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.] 2
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69452-107-13 69452010713 30 TABLET, CHEWABLE in 1 BOTTLE (69452-107-13) 2014-12-01 0000-00-00 No No Current 69452-107-19 69452010719 90 TABLET, CHEWABLE in 1 BOTTLE (69452-107-19) 2014-12-01 0000-00-00 No No Current 69452-107-32 69452010732 1000 TABLET, CHEWABLE in 1 BOTTLE (69452-107-32) 2014-12-01 0000-00-00 No No Current