Montelukast Sodium
- Product NDC
- 68788-9439
- 11-digit product format
- 687889439
- Labeler code
- 68788
- Product ID
- 68788-9439_e486a9da-5021-47e9-ae8d-bb0f76655a0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA091588
- Marketing category
- ANDA
- Marketing start
- 2014-05-05
- 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
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-9439 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 68788-9439 | 68788-9439-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68788-9439 | 68788-9439-2 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68788-9439 | 68788-9439-3 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68788-9439 | 68788-9439-4 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68788-9439 | 68788-9439-6 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68788-9439 | 68788-9439-9 | D | Discontinued by firm | 2026-08-17 |
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.
| 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 | 68788-9439-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9439-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9439-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9439-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9439-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9439-3 | 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 | 68788-9439-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9439-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9439-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9439-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9439-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9439-3 | 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 | 68788-9439-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9439-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9439-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9439-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9439-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9439-3 | 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 | 68788-9439-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9439-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9439-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9439-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9439-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9439-3 | 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 | 68788-9439-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9439-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9439-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9439-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9439-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9439-3 | 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 | 68788-9439-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9439-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9439-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9439-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9439-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9439-3 | 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 | 68788-9439-9 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9439-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9439-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9439-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9439-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9439-3 | 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 | 68788-9439-9 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9439-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9439-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9439-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9439-6 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9439-3 | 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 | 68788-9439-9 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-9439-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-9439-2 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091588-001 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | ||
| A091588-002 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 |
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.
| 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 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091588-001 | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091588-002 | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE / ORAL | 2012-08-03 | bb7c543d1eb4… |