Prescription drug · ANDA
Enalapril maleate oral solution (enalapril maleate) NDC 72603-247
Enalapril maleate 1 mg/mL · Solution · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-247-01 | 72603024701 | 1 BOTTLE in 1 CARTON (72603-247-01) / 150 mL in 1 BOTTLEMarketed from May 1, 2024 |
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 oral solution
- Generic name (nonproprietary)
- enalapril maleate
- Active ingredients
- Enalapril maleate — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214467
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 72603-247_16595fbf-a903-56fc-e063-6294a90a4710SPL ID 16595fbf-a903-56fc-e063-6294a90a4710SPL set ID 19606da3-c6b0-40a5-9690-77fc37072b51RxCUI 1435624UNII 9O25354EPJUPC 0372603247015
- 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
N472603024701followed by a unit qualifier and the quantityPackage 72603-0247-01. 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)
Enalapril maleate is an angiotensin-converting enzyme inhibitor indicated for: • treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • treatment of symptomatic heart failure. ( 1.2 ) • treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. ( 1.3 ) 1.1 Hypertension Enalapril maleate oral solution is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one mon…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214467
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 oral solutionenalapril maleate | Enalapril maleate 1 mg/mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-020 |
- openFDA data updated
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