Prescription drug · ANDA
Enalapril Maleate NDC 43547-547
Enalapril maleate 10 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-547-03 | 43547054703 | 30 TABLET in 1 BOTTLE (43547-547-03)Marketed from Jul 31, 2022 | |
| 43547-547-09 | 43547054709 | 90 TABLET in 1 BOTTLE (43547-547-09)Marketed from Jul 31, 2022 | |
| 43547-547-10 | 43547054710 | 100 TABLET in 1 BOTTLE (43547-547-10)Marketed from Jul 31, 2022 | |
| 43547-547-11 | 43547054711 | 1000 TABLET in 1 BOTTLE (43547-547-11)Marketed from Jul 31, 2022 | |
| 43547-547-50 | 43547054750 | 500 TABLET in 1 BOTTLE (43547-547-50)Marketed from Jul 31, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Enalapril Maleate
- Generic name (nonproprietary)
- enalapril maleate
- Active ingredients
- Enalapril maleate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213273
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 43547-547_f83529df-fce5-42ce-bcd4-c7f61f2a0936SPL ID f83529df-fce5-42ce-bcd4-c7f61f2a0936SPL set ID 0c829189-fba2-48f8-a23f-d5471a0345f6RxCUI 858804, 858810, 858813, 858817UNII 9O25354EPJUPC 0343547548100, 0343547546106, 0343547547103, 0343547545109
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443547054703followed by a unit qualifier and the quantityPackage 43547-0547-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Hypertension Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive. Heart Failure Enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets improve symptoms, increase survival, and decrease the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Tr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213273
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Coupler LLC | 67046-1504 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2382 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-318 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-548 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-545 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-546 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-329 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9604 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3408 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4011 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Coupler LLC | 67046-0798 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8320 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9698 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Preferred Pharmaceuicals Inc. | 68788-8385 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3572 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3537 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1254 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7302 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8437 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-575 |
Showing 20 of 25.
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.