Prescription drug · ANDA
Enalapril maleate NDC 68645-606
Enalapril maleate 10 mg/1 · Tablet · Oral · Legacy Pharmaceutical Packaging, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68645-606-90 | 68645060690 | 90 TABLET in 1 BOTTLE (68645-606-90)Marketed from Nov 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
- Generic name (nonproprietary)
- enalapril maleate
- Active ingredients
- Enalapril maleate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075479
- Marketing start
- Marketing end
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 68645-606_4cc2b0e8-aa06-7a22-e063-6394a90afb7eSPL ID 4cc2b0e8-aa06-7a22-e063-6394a90afb7eSPL set ID ed7536f1-9a7d-4519-e053-2a95a90a4a65RxCUI 858810, 858813, 858817UNII 9O25354EPJUPC 0368645606903, 0368645607900, 0368645605906
- 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
N468645060690followed by a unit qualifier and the quantityPackage 68645-0606-90. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Hypertension Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, He…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075479
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 2.5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-704 |
| Enalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-705 |
| Enalapril maleate | Enalapril maleate 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-006 |
| Enalapril maleate | Enalapril maleate 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-058 |
| Enalapril maleate | Enalapril maleate 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6437 |
| Enalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-110 |
| Enalapril maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7309 |
| Enalapril maleate | Enalapril maleate 10 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-772 |
| Enalapril maleate | Enalapril maleate 20 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-773 |
| Enalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-605 |
| Enalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7310 |
| Enalapril maleate | Enalapril maleate 20 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-607 |
| Enalapril maleate | Enalapril maleate 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7311 |
| Enalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-590 |
| Enalapril maleate | Enalapril maleate 2.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-589 |
| Enalapril maleate | Enalapril maleate 10 mg/1 | TabletOral | Chartwell RX, LLC | 62135-591 |
| Enalapril maleate | Enalapril maleate 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7312 |
| Enalapril maleate | Enalapril maleate 20 mg/1 | TabletOral | Chartwell RX, LLC | 62135-592 |
| Enalapril maleate | Enalapril maleate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7222 |
| Enalapril maleate | Enalapril maleate 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4153 |
- openFDA data updated
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