Prescription drug · ANDA
Enalapril Maleate NDC 50090-3378
Enalapril maleate 5 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3378-0 | 50090337800 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-3378-0)Marketed from Nov 28, 2014 | |
| 50090-3378-1 | 50090337801 | 100 TABLET in 1 BOTTLE (50090-3378-1)Marketed from Feb 22, 2018 | |
| 50090-3378-3 | 50090337803 | 90 TABLET in 1 BOTTLE (50090-3378-3)Marketed from Nov 19, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075657
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 50090-3378_fc9fb737-93aa-4d2e-a840-ec662f356429SPL ID fc9fb737-93aa-4d2e-a840-ec662f356429SPL set ID 0ad4bfb4-62db-4759-af60-88eb031d125aRxCUI 858813UNII 9O25354EPJ
- 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
N450090337800followed by a unit qualifier and the quantityPackage 50090-3378-00. 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)
INDICATIONS AND USAGE Hypertension Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. Heart Failure Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of sur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075657
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 | Enalapril maleate 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4256 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Proficient Rx LP | 63187-977 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6712 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-4560 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-183 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-184 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-186 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1910 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9649 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4037 |
| Enalapril Maleate | Enalapril maleate 5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4038 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4040 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-828 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2252 |
| Enalapril Maleate | Enalapril maleate 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-341 |
| Enalapril Maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7895 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4245 |
| Enalapril Maleate | Enalapril maleate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2608 |