Prescription drug · ANDA
Fosinopril Sodium (Fosinopril) NDC 69097-857
Fosinopril sodium 20 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-857-05 | 6909708570569097085705 | 90 TABLET in 1 BOTTLE (69097-857-05)Marketed from Jun 16, 2016 | |
| 69097-857-15 | 6909708571569097085715 | 1000 TABLET in 1 BOTTLE (69097-857-15)Marketed from Jun 16, 2016 |
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
- Active ingredients
- Fosinopril sodium — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- 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 69097-857_6d672087-9b6a-4afe-8c3e-0616943a82cfSPL ID 6d672087-9b6a-4afe-8c3e-0616943a82cfSPL set ID 736fe52f-69fb-48b2-b1c5-f06531878538RxCUI 857169, 857183, 857187UNII NW2RTH6T2NUPC 0369097857059, 0369097856052, 0369097858056
- 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
N469097085705followed by a unit qualifier and the quantityPackage 69097-0857-05. 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.
About NDC 69097-857
- What is NDC 69097-857?
- 69097-857 is the product NDC for Fosinopril Sodium (fosinopril), Fosinopril sodium 20 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fosinopril Sodium (Fosinopril).
- What is the active ingredient?
- Fosinopril sodium.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fosinopril Sodium?
- 17 other product NDCs are listed under this name. See all Fosinopril Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fosinopril Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fosinopril sodiumfosinopirl sodium | Fosinopril sodium 10 mg/1 | TabletOral | Solco Healthcare LLC | 43547-386 | 43547-0386-0943547-0386-11 |
| Fosinopril sodium | Fosinopril sodium 20 mg/1 | TabletOral | Solco Healthcare LLC | 43547-387 | 43547-0387-0943547-0387-11 |
| Fosinopril sodium | Fosinopril sodium 40 mg/1 | TabletOral | Solco Healthcare LLC | 43547-388 | 43547-0388-0943547-0388-11 |
| Fosinopril sodium | Fosinopril sodium 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-4743 | 50090-4743-0050090-4743-01 |
| Fosinopril sodiumfosinopirl sodium | Fosinopril sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0726 | 71335-0726-0171335-0726-0271335-0726-03+1 more |
| Fosinopril sodium | Fosinopril sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9703 | 71335-9703-0171335-9703-0271335-9703-03 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2977 | 50090-2977-00 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-856 | 69097-0856-0569097-0856-15 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 40 mg/1 | TabletOral | Cipla USA Inc. | 69097-858 | 69097-0858-0569097-0858-15 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0187 | 71335-0187-0171335-0187-02 |
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 | A-S Medication Solutions | 50090-2977 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-856 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 40 mg/1 | TabletOral | Cipla USA Inc. | 69097-858 |
| Fosinopril Sodiumfosinopril | Fosinopril sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0187 |
| 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 20 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-201 |
| Fosinopril sodium | Fosinopril sodium 40 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-202 |