Prescription drug · ANDA
Foscarnet Sodium NDC 68083-389
Foscarnet sodium 24 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-389-01 | 68083038901 | 1 BAG in 1 CARTON (68083-389-01) / 250 mL in 1 BAGMarketed from Apr 21, 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
- Gland Pharma Limited
- 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 68083-389_e7d4415b-96cc-4f7b-b639-7369baf4871aSPL ID e7d4415b-96cc-4f7b-b639-7369baf4871aSPL set ID d4048736-389f-48d8-aadd-6bc76d604ddbRxCUI 1734377UNII 964YS0OOG1UPC 0368083389017
- 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
N468083038901followed by a unit qualifier and the quantityPackage 68083-0389-01. 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 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 | Sagent Pharmaceuticals | 25021-189 |
| Foscarnet Sodium | Foscarnet sodium 6000 mg/250mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-089 |