Prescription drug · ANDA
Foscarnet Sodium NDC 25021-189
Foscarnet sodium 24 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-189-84 | 25021018984 | 10 BAG in 1 CARTON (25021-189-84) / 250 mL in 1 BAGMarketed from May 15, 2021 |
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)
- Foscarnet Sodium
- Generic name (nonproprietary)
- foscarnet sodium
- Active ingredients
- Foscarnet sodium — 24 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213001
- Marketing start
- Listing expires
- Other FDA classes
- Chelating Activity (Mechanism)DNA Polymerase Inhibitors (Mechanism)Pyrophosphate Analog (EXT)
- Identifiers
- Product ID 25021-189_f5829ec8-15e6-43a4-a5f0-68ea0cddb8c8SPL ID f5829ec8-15e6-43a4-a5f0-68ea0cddb8c8SPL set ID 2f49c1bc-0828-4e5c-a3c0-81e997213b0eRxCUI 1734377UNII 964YS0OOG1
- Pharmacologic class
- Pyrophosphate Analog DNA Polymerase 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N425021018984followed by a unit qualifier and the quantityPackage 25021-0189-84. 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 CMV Retinitis Foscarnet sodium injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with foscarnet sodium injection and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS. Mucocutaneous Acyclovir Resistant HSV Infections Foscarnet sodium injection is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213001
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 |
|---|---|---|---|---|
| Foscarnet Sodium | Foscarnet sodium 24 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-389 |
| Foscarnet Sodium | Foscarnet sodium 6000 mg/250mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-089 |