Enalapril Maleate
- Product NDC
- 43547-545
- 11-digit product format
- 435470545
- Labeler code
- 43547
- Product ID
- 43547-545_c3c8f70a-800d-40f1-8f11-0cc49c51d67c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA213273
- Marketing category
- ANDA
- Marketing start
- 2022-07-31
- Substance
- ENALAPRIL MALEATE
- Active strength
- 2.5 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
- Enalapril Maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENALAPRIL MALEATE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9O25354EPJ |
| Rxcui | 858804, 858810, 858813, 858817 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-545-03 | Enalapril Maleate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 43547-545-09 | Enalapril Maleate | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 43547-545-10 | Enalapril Maleate | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 43547-545-11 | Enalapril Maleate | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 43547-545-50 | Enalapril Maleate | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-545 | ENALAPRIL MALEATE TABLET [SOLCO HEALTHCARE US, LLC] | 2 | Current NDC, Legacy NDC, 5 package rows | 20250124_0c829189-fba2-48f8-a23f-d5471a0345f6.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 |
|---|
| 43547-545-03 | 43547054503 | 30 TABLET in 1 BOTTLE (43547-545-03) | 30 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |
| 43547-545-09 | 43547054509 | 90 TABLET in 1 BOTTLE (43547-545-09) | 90 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |
| 43547-545-10 | 43547054510 | 100 TABLET in 1 BOTTLE (43547-545-10) | 100 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |
| 43547-545-11 | 43547054511 | 1000 TABLET in 1 BOTTLE (43547-545-11) | 1000 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |
| 43547-545-50 | 43547054550 | 500 TABLET in 1 BOTTLE (43547-545-50) | 500 tablet | 2022-07-31 | 0000-00-00 | No | No | Current |