Prescription drug · ANDA
Fosinopril Sodium NDC 62135-043
Fosinopril sodium 40 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-043-90 | 62135004390 | 90 TABLET in 1 BOTTLE (62135-043-90)Marketed from Jun 1, 2023 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076483
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-043_40d2b698-02dc-4589-e063-6394a90afb52SPL ID 40d2b698-02dc-4589-e063-6394a90afb52SPL set ID ff1323cc-7ad8-488d-94a7-a11555db78a7RxCUI 857169, 857183, 857187UNII NW2RTH6T2NUPC 0362135042905, 0362135043902, 0362135041908
- 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
N462135004390followed by a unit qualifier and the quantityPackage 62135-0043-90. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Fosinopril sodium tablets are indicated for the treatment of hypertension. They 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 tablets, 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 tablets do no…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076483
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 | Chartwell RX, LLC | 62135-041 |
| Fosinopril Sodium | Fosinopril sodium 20 mg/1 | TabletOral | Chartwell RX, LLC | 62135-042 |