Losartan Potassium
- Product NDC
- 53002-3638
- 11-digit product format
- 530023638
- Labeler code
- 53002
- Product ID
- 53002-3638_1516cd98-d09a-498a-a028-099dcff594a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA203835
- Marketing category
- ANDA
- Marketing start
- 2015-08-19
- Marketing end
- 0000-00-00
- Substance
- LOSARTAN POTASSIUM
- Active strength
- 100 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-3638-0 | 2025-01-30 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
| 53002-3638-3 | 2025-01-30 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
| 53002-3638-9 | 2025-01-30 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
| 53002-3638-0 | 2023-06-08 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
| 53002-3638-3 | 2023-06-08 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
| 53002-3638-9 | 2023-06-08 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
| 53002-3638-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
| 53002-3638-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
| 53002-3638-9 | 2023-01-30 | C162847 | 48780-1 | f386c649-f08f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-3638-0 | Losartan Potassium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 53002-3638-3 | Losartan Potassium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 53002-3638-9 | Losartan Potassium | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3638 | LOSARTAN POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20230609_70570c01-75fd-4d15-8856-a99ff29b7d89.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-3638-0 | 53002363800 | 100 TABLET, FILM COATED in 1 BOTTLE (53002-3638-0) | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-3638-3 | 53002363803 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-3638-3) | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-3638-9 | 53002363809 | 90 TABLET, FILM COATED in 1 BOTTLE (53002-3638-9) | 2020-01-01 | 0000-00-00 | No | No | Current |