Prescription drug · ANDA
Ganciclovir (Ganciclovir sodium) NDC 63323-315
Ganciclovir sodium 500 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-315-94 | 6332303159463323031594 | 25 VIAL in 1 TRAY (63323-315-94) / 10 mL in 1 VIAL (63323-315-41)Marketed from Jun 28, 2010 |
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, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090658
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 63323-315_e51e0b68-6b11-42f5-82a2-87c480cb5c41SPL ID e51e0b68-6b11-42f5-82a2-87c480cb5c41SPL set ID 35addab5-09db-4f8a-9c69-6fbce33ecc37RxCUI 310442UNII 02L083W284UPC 0363323315412
- 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
N463323031594followed by a unit qualifier and the quantityPackage 63323-0315-94. 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 for 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 for 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 for Injection is i…
Excerpt only. Read the full label for complete information.
About NDC 63323-315
- What is NDC 63323-315?
- 63323-315 is the product NDC for Ganciclovir (ganciclovir sodium), Ganciclovir sodium 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ganciclovir (Ganciclovir sodium).
- What is the active ingredient?
- Ganciclovir sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ganciclovir?
- 5 other product NDCs are listed under this name. See all Ganciclovir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ganciclovir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ganciclovirganciclovir sodium | Ganciclovir sodium 50 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9299 | 00143-9299-10 |
| ganciclovirganciclovir sodium | Ganciclovir sodium 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-089 | 70436-0089-55 |
| Ganciclovirganciclovir sodium | Ganciclovir sodium 500 mg/10mL | Injection, SolutionIntravenous | Pharmascience Inc. | 51817-171 | 51817-0171-0151817-0171-02 |
| ganciclovirganciclovir sodium | Ganciclovir sodium 50 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-185 | 25021-0185-10 |
| Ganciclovir | Ganciclovir sodium 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Par Health USA, LLC | 42023-173 | 42023-0173-25 |