Prescription drug · ANDA
Enalapril maleate oral solution (Enalapril maleate) NDC 31722-020
Enalapril maleate 1 mg/mL · Solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-020-15 | 3172200201531722002015 | 1 BOTTLE in 1 CARTON (31722-020-15) / 150 mL in 1 BOTTLEMarketed from Feb 14, 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
- Active ingredients
- Enalapril maleate — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- 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 31722-020_d7a8fe4e-7b8e-05b0-e053-2995a90a6291SPL ID d7a8fe4e-7b8e-05b0-e053-2995a90a6291SPL set ID b63bdaa6-b57b-417b-9a79-29f1fd5bbf08RxCUI 1435624UNII 9O25354EPJUPC 0331722020152
- 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
N431722002015followed by a unit qualifier and the quantityPackage 31722-0020-15. 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.
About NDC 31722-020
- What is NDC 31722-020?
- 31722-020 is the product NDC for Enalapril maleate oral solution (enalapril maleate), Enalapril maleate 1 mg/mL solution, listed with the FDA by Camber Pharmaceuticals, 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 | Bionpharma Inc. | 69452-237 | 69452-0237-46 |
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 | NorthStar RxLLC | 72603-247 |