Prescription drug · ANDA
Enalapril maleate oral solution (Enalapril maleate) NDC 69452-237
Enalapril maleate 1 mg/mL · Solution · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-237-46 | 6945202374669452023746 | 1 BOTTLE in 1 CARTON (69452-237-46) / 150 mL in 1 BOTTLEMarketed from Aug 11, 2021 |
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
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212408
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 69452-237_23614d4e-d023-1bfc-e063-6394a90a42beSPL ID 23614d4e-d023-1bfc-e063-6394a90a42beSPL set ID 9391b8d8-2217-4838-8976-1a5ad90ef4caRxCUI 1435624UNII 9O25354EPJUPC 0369452237465
- 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
N469452023746followed by a unit qualifier and the quantityPackage 69452-0237-46. 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 is an angiotensin-converting enzyme inhibitor indicated for: 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 ) 1.2 Heart Failure Enalapril maleate oral solution is indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In these patients, enalapril maleate oral solution increases survival and decreases the frequency of hospitalization. 1.3 Asymptomatic Left Ventricular Dysfunction In clinically stable asymptomatic patients with left ventricular dysfunction (ejecti…
Excerpt only. Read the full label for complete information.
About NDC 69452-237
- What is NDC 69452-237?
- 69452-237 is the product NDC for Enalapril maleate oral solution (enalapril maleate), Enalapril maleate 1 mg/mL solution, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Enalapril maleate oral solution (Enalapril maleate).
- What is the active ingredient?
- Enalapril maleate.
- Who is the labeler?
- Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Enalapril maleate oral solution?
- 3 other product NDCs are listed under this name. See all Enalapril maleate oral solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Enalapril maleate oral solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Enalapril maleate oral solutionenalapril maleate | Enalapril maleate 1 mg/mL | SolutionOral | NorthStar RxLLC | 72603-247 | 72603-0247-01 |
| Enalapril Maleate Oral Solution | Enalapril maleate 1 mg/mL | SolutionOral | Ascend Laboratories, LLC | 67877-712 | 67877-0712-81 |
| Enalapril maleate oral solutionenalapril maleate | Enalapril maleate 1 mg/mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-020 | 31722-0020-15 |