Prescription drug · ANDA
Fosinopril sodium NDC 76282-201
Fosinopril sodium 20 mg/1 · Tablet · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-201-10 | 76282020110 | 1000 TABLET in 1 BOTTLE (76282-201-10)Marketed from Jun 21, 2005 | |
| 76282-201-90 | 76282020190 | 90 TABLET in 1 BOTTLE (76282-201-90)Marketed from Jun 21, 2005 |
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)
- Fosinopril sodium
- Generic name (nonproprietary)
- fosinopril sodium
- Active ingredients
- Fosinopril sodium — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077222
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 76282-201_ed121c1b-359c-471e-913c-4afdf9102c34SPL ID ed121c1b-359c-471e-913c-4afdf9102c34SPL set ID e2ff3171-a17a-456a-9272-ca1682b01d19RxCUI 857169, 857183, 857187UNII NW2RTH6T2NUPC 0376282202907, 0376282201900, 0376282200903
- 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
N476282020110followed by a unit qualifier and the quantityPackage 76282-0201-10. 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 Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION ). In using fosinopril sodium, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077222
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 |
|---|---|---|---|---|
| Fosinopril Sodiumfosinopril | Fosinopril sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0381 |
| Fosinopril sodium | Fosinopril sodium 10 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-200 |
| Fosinopril sodium | Fosinopril sodium 40 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-202 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 40 mg/1 | TabletOral | Cipla USA Inc. | 69097-858 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-856 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 20 mg/1 | TabletOral | Cipla USA Inc. | 69097-857 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0187 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2977 |