Prescription drug · ANDA
Ganciclovir (ganciclovir sodium) NDC 51817-171
Ganciclovir sodium 500 mg/10mL · Injection, Solution · Intravenous · Pharmascience Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51817-171-01 | 51817017101 | 25 VIAL in 1 CARTON (51817-171-01) / 10 mL in 1 VIALMarketed from Apr 24, 2018 | |
| 51817-171-02 | 51817017102 | 1 VIAL in 1 CARTON (51817-171-02) / 10 mL in 1 VIALMarketed from Dec 15, 2019 |
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
- Generic name (nonproprietary)
- ganciclovir sodium
- Active ingredients
- Ganciclovir sodium — 500 mg/10mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Pharmascience Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207645
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 51817-171_f05916fd-4785-f545-e053-2995a90aa901SPL ID f05916fd-4785-f545-e053-2995a90aa901SPL set ID 3059c2da-d4a7-4aea-828c-20e671cb875cRxCUI 1999531UNII 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
N451817017101followed by a unit qualifier and the quantityPackage 51817-0171-01. 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)
Ganciclovir Injection Ganciclovir Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 ) prevention of CMV disease in adult transplant recipients at risk for CMV disease. ( 1.2 ) 1.1 Treatment of CMV Retinitis Ganciclovir Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1 )]. 1.2 Prevention of CMV Disease in Transplant Recipients Ganciclovir Injection …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207645
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 50 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-185 |