ENALAPRIL MALEATE
- Product NDC
- 69292-544
- 11-digit product format
- 692920544
- Labeler code
- 69292
- Product ID
- 69292-544_d6d5b131-5d92-41b7-829f-9de587a951d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- enalapril maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amici Pharma, Inc
- Application
- ANDA075483
- Marketing category
- ANDA
- Marketing start
- 2025-10-15
- Substance
- ENALAPRIL MALEATE
- Active strength
- 10 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 | 10 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 |
|---|
| 69292-544-01 | ENALAPRIL MALEATE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 69292-544-10 | ENALAPRIL MALEATE | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69292-544-01 | 69292054401 | 100 TABLET in 1 BOTTLE (69292-544-01) | 100 tablet | 2025-10-15 | No | No | Current |
| 69292-544-10 | 69292054410 | 1000 TABLET in 1 BOTTLE (69292-544-10) | 1000 tablet | 2025-10-15 | No | No | Current |