montelukast sodium
- Product NDC
- 50090-4919
- 11-digit product format
- 500904919
- Labeler code
- 50090
- Product ID
- 50090-4919_839c07d8-1bf5-44e1-9b5b-2b0939cc1f82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA204290
- Marketing category
- ANDA
- Marketing start
- 2016-01-01
- Marketing end
- 0000-00-00
- Substance
- MONTELUKAST SODIUM
- Active strength
- 10 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 50090-4919 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 50090-4919 | 50090-4919-0 | I | Inactivated by FDA | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 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 | 50090-4919-0 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204290-001 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204290-001 | 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.
| 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 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A204290-001 | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2015-10-08 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204290-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204290-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204290-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204290-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204290-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204290-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204290-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204290-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204290-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204290-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204290-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204290-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204290-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204290-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204290-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204290-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204290-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204290-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204290-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204290-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A204290-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204290-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A204290-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A204290-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A204290-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A204290-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A204290-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204290-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204290-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A204290-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A204290-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204290-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204290-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204290-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204290-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A204290-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A204290-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204290-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A204290-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A204290-001 | AB | 1 | e64feba35796… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8d8a355b-240d-8c38-7331-c9e3c1068a33 | Product name | 9 | 20161220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4919-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4a09-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4919-0 | montelukast sodium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4919 | MONTELUKAST SODIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC, 1 package rows | 20210615_9b560283-cfa3-4289-b4cc-3f1237e668c3.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| montelukast sodium | MONTELUKAST SODIUM | Preferred Pharmaceuticals Inc. | 1eeb3123-9e93-4681-8096-800a7c7acf8a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 204290 ANDA204290 |
| montelukast sodium | MONTELUKAST SODIUM | NuCare Pharmaceuticals,Inc. | a7c11cbe-0834-27a5-e053-2995a90ac43f | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | 204290 ANDA204290 |
| montelukast sodium | MONTELUKAST SODIUM | Bryant Ranch Prepack | 9beb1510-f3af-4269-a9d0-e2bd41ac369b | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 204290 ANDA204290 |
| montelukast sodium | MONTELUKAST SODIUM | Unichem Pharmaceuticals (USA), Inc. | 9e375c07-70db-458c-9336-22a7037b0a5f | 2023-06-12 | Boxed warning, Warnings, Adverse reactions | 204290 ANDA204290 |
| montelukast sodium | MONTELUKAST SODIUM | Proficient Rx LP | 2ce48faf-4504-488a-8b20-3e8d4f008fb2 | 2022-06-01 | Warnings, Adverse reactions | 204290 ANDA204290 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 200224 | montelukast sodium 10 MG Oral Tablet | PSN | 9b560283-cfa3-4289-b4cc-3f1237e668c3 | 5 |
| 200224 | montelukast 10 MG Oral Tablet | SCD | 9b560283-cfa3-4289-b4cc-3f1237e668c3 | 5 |
| 200224 | montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet | SY | 9b560283-cfa3-4289-b4cc-3f1237e668c3 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-4919-0 | 50090491900 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-4919-0) | 2020-02-18 | 0000-00-00 | No | No | Current |