Prescription drug · NDA
Vasotec (enalapril maleate) NDC 0187-0142
Enalapril maleate 10 mg/1 · Tablet · Oral · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0142-10 | 00187014210 | 1000 TABLET in 1 BOTTLE (0187-0142-10)Marketed from Dec 24, 1985 | |
| 0187-0142-30 | 00187014230 | 30 TABLET in 1 BOTTLE (0187-0142-30)Marketed from Dec 24, 1985 | |
| 0187-0142-90 | 00187014290 | 90 TABLET in 1 BOTTLE (0187-0142-90)Marketed from Dec 24, 1985 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Vasotec
- Generic name (nonproprietary)
- enalapril maleate
- Active ingredients
- Enalapril maleate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bausch Health US LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018998
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 0187-0142_1be6ec2b-1c20-4ff4-a8ff-cd23e3de9fa4SPL ID 1be6ec2b-1c20-4ff4-a8ff-cd23e3de9fa4SPL set ID 39631f1f-5d19-43c1-b504-bf56d991ed97RxCUI 858804, 858806, 858810, 858812, 858813, 858815, 858817, 858819UNII 9O25354EPJUPC 0301870143300
- 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
N400187014210followed by a unit qualifier and the quantityPackage 00187-0142-10. 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 VASOTEC is indicated for the treatment of hypertension. VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive. Heart Failure VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY , Heart Failure , Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dys…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018998
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 10 mg/1 | TabletOral | Proficient Rx LP | 71205-075 |
| Vasotecenalapril maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Bausch Health US LLC | 0187-0140 |
| Vasotecenalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | Bausch Health US LLC | 0187-0141 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | OCEANSIDE PHARMACEUTICALS | 68682-711 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | OCEANSIDE PHARMACEUTICALS | 68682-710 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | OCEANSIDE PHARMACEUTICALS | 68682-712 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | OCEANSIDE PHARMACEUTICALS | 68682-713 |
| Vasotecenalapril maleate | Enalapril maleate 20 mg/1 | TabletOral | Bausch Health US LLC | 0187-0143 |