Prescription drug · ANDA
ganciclovir sodium NDC 70436-231
Ganciclovir sodium 500 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-231-55 | 70436023155 | 25 VIAL in 1 CARTON (70436-231-55) / 10 mL in 1 VIALMarketed from Sep 1, 2024 |
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)
- ganciclovir sodium
- Generic name (nonproprietary)
- ganciclovir sodium
- Active ingredients
- Ganciclovir sodium — 500 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204204
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 70436-231_2ac6c72f-6f19-825c-e063-6294a90af661SPL ID 2ac6c72f-6f19-825c-e063-6294a90af661SPL set ID cd293b9d-b573-4656-8574-19d7db870a9bRxCUI 310442UNII 02L083W284
- Pharmacologic class
- Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor; Nucleoside Analog Antiviral
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
N470436023155followed by a unit qualifier and the quantityPackage 70436-0231-55. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 204204
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 |
|---|---|---|---|---|
| ganciclovirganciclovir sodium | Ganciclovir sodium 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-089 |