Enalapril Maleate
- Product NDC
- 53808-0648
- 11-digit product format
- 538080648
- Labeler code
- 53808
- Product ID
- 53808-0648_266007f1-3e2f-4142-92c2-cdb20fb73f99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enalapril Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA075479
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- ENALAPRIL MALEATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
| 628e4aea-ca7c-e8c4-6fcc-d791c4deb0ae | Product name | 1 | 20140508 |
| 78637fb0-95c8-441f-e4b4-db1274b6f956 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0648-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cdad-621f-e053-dbdaa90a74ad | ENALAPRIL MALEATE TABLETS USP, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0648-1 | Enalapril Maleate | 30 in 1 BLISTER PACK | TABLET | 30 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ENALAPRIL MALEATE | ACTIVE INGREDIENT | 9O25354EPJ | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| ENALAPRIL | ACTIVE MOIETY | 69PN84IO1A | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0648 | ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 3 | Legacy NDC, 1 package rows | 20100819_d42cd274-ee43-4be7-b006-24dce0fb6cf6.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858804 | enalapril maleate 2.5 MG Oral Tablet | PSN | d42cd274-ee43-4be7-b006-24dce0fb6cf6 | 3 |
| 858810 | enalapril maleate 20 MG Oral Tablet | PSN | d42cd274-ee43-4be7-b006-24dce0fb6cf6 | 3 |
| 858804 | enalapril maleate 2.5 MG Oral Tablet | SCD | d42cd274-ee43-4be7-b006-24dce0fb6cf6 | 3 |
| 858810 | enalapril maleate 20 MG Oral Tablet | SCD | d42cd274-ee43-4be7-b006-24dce0fb6cf6 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0648-1 | 53808064801 | 30 in 1 BLISTER PACK | Historical |