Prescription drug · ANDA
Enalapril Maleate Oral Solution NDC 67877-712
Enalapril maleate 1 mg/mL · Solution · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-712-81 | 67877071281 | 150 mL in 1 BOTTLE (67877-712-81)Marketed from Sep 5, 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 Oral Solution
- Generic name (nonproprietary)
- enalapril maleate oral solution
- Active ingredients
- Enalapril maleate — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213714
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 67877-712_186acff5-dbb8-4507-963a-0accd004a6feSPL ID 186acff5-dbb8-4507-963a-0accd004a6feSPL set ID 964d561a-2e04-4ad9-9762-932419ee19aeRxCUI 1435624UNII 9O25354EPJUPC 0367877712819
- 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
N467877071281followed by a unit qualifier and the quantityPackage 67877-0712-81. 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 is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month [see Pediatric Us…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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