Enalapril Maleate and Hydrochlorothiazide
- Product NDC
- 51672-4045
- 11-digit product format
- 516724045
- Labeler code
- 51672
- Product ID
- 51672-4045_1130a62d-94e3-2dc6-e063-6394a90a8a67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril Maleate and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- ANDA075788
- Marketing category
- ANDA
- Marketing start
- 2001-09-18
- Substance
- ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
- Active strength
- 5; 12.5 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
- Enalapril Maleate and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENALAPRIL MALEATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9O25354EPJ, 0J48LPH2TH |
| Rxcui | 858824, 858828 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-4045-1 | Enalapril Maleate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
| 51672-4045-3 | Enalapril Maleate and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Enalapril Maleate | ACTIVE INGREDIENT | 9O25354EPJ | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| Hydrochlorothiazide | ACTIVE INGREDIENT | 0J48LPH2TH | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| Enalaprilat Anhydrous | ACTIVE MOIETY | Q508Q118JM | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| Hydrochlorothiazide | ACTIVE MOIETY | 0J48LPH2TH | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| sodium bicarbonate | INACTIVE INGREDIENT | 8MDF5V39QO | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-4045 | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240509_7cb92cf2-46f2-4379-937c-168d230e43a4.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 |
|---|
| 51672-4045-1 | 51672404501 | 100 TABLET in 1 BOTTLE (51672-4045-1) | 100 tablet | 2001-09-18 | 0000-00-00 | No | No | Current |
| 51672-4045-3 | 51672404503 | 1000 TABLET in 1 BOTTLE (51672-4045-3) | 1000 tablet | 2001-09-18 | 0000-00-00 | No | No | Current |