Enalapril maleate
- Product NDC
- 0904-7311
- 11-digit product format
- 009047311
- Labeler code
- 0904
- Product ID
- 0904-7311_e94d8a16-0294-4f3e-b77a-29ed1a94d3a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075479
- Marketing category
- ANDA
- Marketing start
- 2025-08-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Enalapril maleate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ENALAPRIL MALEATE | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9O25354EPJ |
| Rxcui | 858804, 858810, 858813, 858817 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5ffbd585-373a-fcf5-c6c8-1f04bf28013e | Product name | 3 | 20250331 |
| 2c0b09af-323c-477d-9a19-d8165aefa3b0 | Product name | 4 | 20250107 |
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 628e4aea-ca7c-e8c4-6fcc-d791c4deb0ae | Product name | 1 | 20140508 |
| 78637fb0-95c8-441f-e4b4-db1274b6f956 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7311-61 | Enalapril maleate | 1 in 1 BLISTER PACK | TABLET | 1 | 3 | |
| 0904-7311-61 | Enalapril maleate | 100 in 1 CARTON | TABLET | 100 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7311-61 | EA - Each | 0904-7311 | fd51e7bb-103f-4e5b-bc9a-114fcd07c336 | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858817 | enalapril maleate 10 MG Oral Tablet | PSN | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 3 |
| 858804 | enalapril maleate 2.5 MG Oral Tablet | PSN | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 3 |
| 858810 | enalapril maleate 20 MG Oral Tablet | PSN | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 3 |
| 858813 | enalapril maleate 5 MG Oral Tablet | PSN | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 3 |
| 858817 | enalapril maleate 10 MG Oral Tablet | SCD | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 3 |
| 858804 | enalapril maleate 2.5 MG Oral Tablet | SCD | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 3 |
| 858810 | enalapril maleate 20 MG Oral Tablet | SCD | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 3 |
| 858813 | enalapril maleate 5 MG Oral Tablet | SCD | 8fe8dc52-dee6-4d33-b798-e90128011f46 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0904-7311-61 | 00904731161 | 100 BLISTER PACK in 1 CARTON (0904-7311-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2025-08-28 | No | No | Historical |