Lotensin
- Product NDC
- 30698-449
- 11-digit product format
- 306980449
- Labeler code
- 30698
- Product ID
- 30698-449_40029d07-adfa-0cc3-e063-6294a90a4cd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benazepril hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Validus Pharmaceuticals LLC
- Application
- NDA019851
- Marketing category
- NDA
- Marketing start
- 1991-06-21
- Substance
- BENAZEPRIL HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lotensin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENAZEPRIL HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N1SN99T69T |
| Rxcui | 898687, 898689, 898690, 898692, 898719, 898721 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 30698-449-01 | 2025-09-30 | C162847 | 48780-1 | f386c64a-0c7a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOTENSIN ® safely and effectively. See full prescribing information for use LOTENSIN ® . LOTENSIN ® (benazepril hydrochloride, USP) tablets, for oral use Initial U.S. Approval: 1991 |
| 30698-449-01 | 2025-01-30 | C162847 | 48780-1 | f386c64a-0c7a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOTENSIN ® safely and effectively. See full prescribing information for use LOTENSIN ® . LOTENSIN ® (benazepril hydrochloride, USP) tablets, for oral use Initial U.S. Approval: 1991 |
| 30698-449-01 | 2023-02-17 | C162847 | 48780-1 | f386c64a-0c7a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOTENSIN ® safely and effectively. See full prescribing information for use LOTENSIN ® . LOTENSIN ® (benazepril hydrochloride, USP) tablets, for oral use Initial U.S. Approval: 1991 |
| 30698-449-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0c7a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LOTENSIN ® safely and effectively. See full prescribing information for use LOTENSIN ® . LOTENSIN ® (benazepril hydrochloride, USP) tablets, for oral use Initial U.S. Approval: 1991 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 30698-449-01 | Lotensin | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 30698-449 | LOTENSIN (BENAZEPRIL HYDROCHLORIDE) TABLET [VALIDUS PHARMACEUTICALS LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20230219_2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 30698-449-01 | 30698044901 | 100 TABLET in 1 BOTTLE (30698-449-01) | 100 tablet | 1991-06-21 | 0000-00-00 | No | No | Current |