ENALAPRIL MALEATE
- Product NDC
- 55648-926
- 11-digit product format
- 556480926
- Labeler code
- 55648
- Product ID
- 55648-926_c6ea4a09-66d5-4f33-9f17-9c63cb59e4b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ENALAPRIL MALEATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Wockhardt Limited
- Application
- ANDA075483
- Marketing category
- ANDA
- Marketing start
- 2009-12-11
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 55648-926-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-26cb-f424-e053-dadaa90a57ce | ENALAPRIL MALEATE TABLETS, USP |
| 55648-926-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-26cb-f424-e053-dadaa90a57ce | ENALAPRIL MALEATE TABLETS, USP |
| 55648-926-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-26cb-f424-e053-dadaa90a57ce | ENALAPRIL MALEATE TABLETS, USP |
| 55648-926-07 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-26cb-f424-e053-dadaa90a57ce | ENALAPRIL MALEATE TABLETS, USP |
| 55648-926-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-26cb-f424-e053-dadaa90a57ce | ENALAPRIL MALEATE TABLETS, USP |
| 55648-926-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-26cb-f424-e053-dadaa90a57ce | ENALAPRIL MALEATE TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55648-926-01 | ENALAPRIL MALEATE | 90 in 1 BOTTLE | TABLET | 90 | 3 | |
| 55648-926-02 | ENALAPRIL MALEATE | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 55648-926-03 | ENALAPRIL MALEATE | 1000 in 1 BOTTLE | TABLET | 1000 | 3 | |
| 55648-926-07 | ENALAPRIL MALEATE | 10 in 1 CARTON | TABLET | 10 | 3 | |
| 55648-926-07 | ENALAPRIL MALEATE | 10 in 1 BLISTER PACK | TABLET | 10 | 3 | |
| 55648-926-09 | ENALAPRIL MALEATE | 40000 in 1 DRUM | TABLET | 40000 | 3 | |
| 55648-926-10 | ENALAPRIL MALEATE | 8000 in 1 DRUM | TABLET | 8000 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ENALAPRIL MALEATE | ACTIVE INGREDIENT | 9O25354EPJ | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 | |
| ENALAPRILAT ANHYDROUS | ACTIVE MOIETY | Q508Q118JM | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 | |
| BROWN IRON OXIDE | INACTIVE INGREDIENT | 1N032N7MFO | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ENALAPRIL MALEATE TABLET [WOCKHARDT LIMITED] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858817 | enalapril maleate 10 MG Oral Tablet | PSN | f1ec6ac1-6b94-40bb-a329-9056f201090c | 3 |
| 858804 | enalapril maleate 2.5 MG Oral Tablet | PSN | f1ec6ac1-6b94-40bb-a329-9056f201090c | 3 |
| 858810 | enalapril maleate 20 MG Oral Tablet | PSN | f1ec6ac1-6b94-40bb-a329-9056f201090c | 3 |
| 858813 | enalapril maleate 5 MG Oral Tablet | PSN | f1ec6ac1-6b94-40bb-a329-9056f201090c | 3 |
| 858817 | enalapril maleate 10 MG Oral Tablet | SCD | f1ec6ac1-6b94-40bb-a329-9056f201090c | 3 |
| 858804 | enalapril maleate 2.5 MG Oral Tablet | SCD | f1ec6ac1-6b94-40bb-a329-9056f201090c | 3 |
| 858810 | enalapril maleate 20 MG Oral Tablet | SCD | f1ec6ac1-6b94-40bb-a329-9056f201090c | 3 |
| 858813 | enalapril maleate 5 MG Oral Tablet | SCD | f1ec6ac1-6b94-40bb-a329-9056f201090c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 55648-926-01 | 55648092601 | 90 in 1 BOTTLE | Historical |
| 55648-926-02 | 55648092602 | 100 in 1 BOTTLE | Historical |
| 55648-926-03 | 55648092603 | 1000 in 1 BOTTLE | Historical |
| 55648-926-07 | 55648092607 | 10 in 1 CARTON | Historical |
| 55648-926-09 | 55648092609 | 40000 in 1 DRUM | Historical |
| 55648-926-10 | 55648092610 | 8000 in 1 DRUM | Historical |