Prescription drug · NDA
Enalapril maleate NDC 52536-401
Enalapril maleate 1 mg/mL · Solution · Oral · Wilshire Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-401-01 | 5253604010152536040101 | 1 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLEMarketed from Apr 8, 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
- Generic name (nonproprietary)
- enalapril maleate
- Active ingredients
- Enalapril maleate — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Wilshire Pharmaceuticals, Inc.NDC labeler code 52536
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208686
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 52536-401_461e14b2-890d-011c-e063-6294a90a0d4cSPL ID 461e14b2-890d-011c-e063-6294a90a0d4cSPL set ID c7934b45-eb6b-44c1-bd2c-ef0fa10850c1RxCUI 1435624UNII 9O25354EPJUPC 0352536401012
- 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
N452536040101followed by a unit qualifier and the quantityPackage 52536-0401-01. 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 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.
About NDC 52536-401
- What is NDC 52536-401?
- 52536-401 is the product NDC for Enalapril maleate, Enalapril maleate 1 mg/mL solution, listed with the FDA by Wilshire Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Enalapril maleate.
- What is the active ingredient?
- Enalapril maleate.
- Who is the labeler?
- Wilshire Pharmaceuticals, Inc., NDC labeler code 52536. 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?
- 97 other product NDCs are listed under this name. See all Enalapril maleate 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 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 | Enalapril maleate 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1254 | 67046-1254-03 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4164 | 68788-4164-0168788-4164-0368788-4164-06+1 more |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4147 | 68788-4147-0068788-4147-0368788-4147-06+1 more |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Coupler LLC | 67046-0798 | 67046-0798-03 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Amici Pharma, Inc | 69292-544 | 69292-0544-0169292-0544-1069292-0544-50 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Amici Pharma, Inc | 69292-540 | 69292-0540-0169292-0540-10 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Amici Pharma, Inc | 69292-542 | 69292-0542-0169292-0542-1069292-0542-50 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Amici Pharma, Inc | 69292-546 | 69292-0546-0169292-0546-10 |
| Enalapril maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7309 | 00904-7309-61 |
| Enalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7310 | 00904-7310-61 |
Other NDCs under NDA 208686
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 |
|---|---|---|---|---|
| Epanedenalapril maleate | Enalapril maleate 1 mg/mL | SolutionOral | Azurity Pharmaceuticals, Inc. | 52652-4001 |