Benazepril Hydrochloride and Hydrochlorothiazide
- Product NDC
- 62559-417
- 11-digit product format
- 625590417
- Labeler code
- 62559
- Product ID
- 62559-417_052493c7-89a3-452e-8140-04dd95f0d9e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benazepril Hydrochloride and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA076342
- Marketing category
- ANDA
- Marketing start
- 2022-11-07
- Substance
- BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
- Active strength
- 20; 25 mg/1; mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benazepril Hydrochloride and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENAZEPRIL HYDROCHLORIDE | 20 mg/1 |
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, N1SN99T69T |
| Rxcui | 898362, 898367, 898372, 898378 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-417-01 | Benazepril Hydrochloride and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-417 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET [ANI PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20221107_e6527adf-8c74-4d81-9199-d56a7fca895e.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 |
|---|
| 62559-417-01 | 62559041701 | 100 TABLET in 1 BOTTLE (62559-417-01) | 100 tablet | 2022-11-07 | 0000-00-00 | No | No | Current |