Prescription drug · ANDA
Enalapril Maleate NDC 16714-444
Enalapril maleate 10 mg/1 · Tablet · Oral · Northstar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-444-01 | 16714044401 | 100 TABLET in 1 BOTTLE (16714-444-01)Marketed from Aug 6, 2015 | |
| 16714-444-02 | 16714044402 | 1000 TABLET in 1 BOTTLE (16714-444-02)Marketed from Aug 6, 2015 |
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
- Labeler
- Northstar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075459
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 16714-444_4bc84994-0116-425c-8dab-ba08b0880b24SPL ID 4bc84994-0116-425c-8dab-ba08b0880b24SPL set ID e109e7b1-4650-4416-9d89-7c1185d5cf48RxCUI 858804, 858810, 858813, 858817UNII 9O25354EPJUPC 0316714445014, 0316714443010
- 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
N416714044401followed by a unit qualifier and the quantityPackage 16714-0444-01. 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)
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 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 improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075459
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 20 mg/1 | TabletOral | Northstar RxLLC | 16714-445 |