Prescription drug · NDA
Foscavir (Foscarnet sodium) NDC 76310-024
Foscarnet sodium 24 mg/mL · Injection, Solution · Intravenous · Clinigen Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76310-024-25 | 7631000242576310002425 | 10 CARTON in 1 CARTON (76310-024-25) / 1 BOTTLE in 1 CARTON (76310-024-15) / 250 mL in 1 BOTTLEMarketed from Jul 9, 2012 |
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)
- Foscavir
- Generic name (nonproprietary)
- foscarnet sodium
- Active ingredients
- Foscarnet sodium — 24 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Clinigen LimitedNDC labeler code 76310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020068
- Marketing start
- Listing expires
- Other FDA classes
- Chelating Activity (Mechanism)DNA Polymerase Inhibitors (Mechanism)Pyrophosphate Analog (EXT)
- Identifiers
- Product ID 76310-024_6792504c-7fa0-4179-9c76-1f6a2ced2832SPL ID 6792504c-7fa0-4179-9c76-1f6a2ced2832SPL set ID a09299d5-9c55-4cef-aed0-3a6a45532289RxCUI 855613, 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
N476310002425followed by a unit qualifier and the quantityPackage 76310-0024-25. 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 FOSCAVIR is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with FOSCAVIR and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCAVIR 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 FOSCAVIR is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. SAFETY AND EFFICACY OF FOSCAVIR HAVE NOT BEEN ES…
Excerpt only. Read the full label for complete information.
About NDC 76310-024
- What is NDC 76310-024?
- 76310-024 is the product NDC for Foscavir (foscarnet sodium), Foscarnet sodium 24 mg/mL injection, solution, listed with the FDA by Clinigen Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Foscavir (Foscarnet sodium).
- What is the active ingredient?
- Foscarnet sodium.
- Who is the labeler?
- Clinigen Limited, NDC labeler code 76310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Foscavir?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.