Prescription drug · ANDA
Fosinopril Sodium (fosinopril) NDC 71335-0381
Fosinopril sodium 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0381-1 | 71335038101 | 30 TABLET in 1 BOTTLE (71335-0381-1)Marketed from Feb 9, 2022 | |
| 71335-0381-2 | 71335038102 | 90 TABLET in 1 BOTTLE (71335-0381-2)Marketed from Feb 9, 2022 | |
| 71335-0381-3 | 71335038103 | 60 TABLET in 1 BOTTLE (71335-0381-3)Marketed from Feb 9, 2022 | |
| 71335-0381-4 | 71335038104 | 28 TABLET in 1 BOTTLE (71335-0381-4)Marketed from Feb 9, 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)
- Fosinopril Sodium
- Generic name (nonproprietary)
- fosinopril
- Active ingredients
- Fosinopril sodium — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-0381_45aabe20-10c6-4b99-989a-2b64bd266114SPL ID 45aabe20-10c6-4b99-989a-2b64bd266114SPL set ID fc38f1bb-f175-4a81-8ed9-c8701efdea35RxCUI 857169UNII NW2RTH6T2N
- 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
N471335038101followed by a unit qualifier and the quantityPackage 71335-0381-01. 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 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 sodium | Fosinopril sodium 10 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-200 |
| Fosinopril sodium | Fosinopril sodium 20 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-201 |
| 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 |