Prescription drug · ANDA
ganciclovir (Ganciclovir sodium) NDC 25021-185
Ganciclovir sodium 50 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-185-10 | 2502101851025021018510 | 25 VIAL in 1 CARTON (25021-185-10) / 10 mL in 1 VIALMarketed from Feb 15, 2018 |
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 — 50 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- 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 25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1SPL ID 696f706f-39d7-4647-a506-2ebf7b956cc1SPL set ID 993151ed-cea7-49a7-a967-fac3e9b3c85fRxCUI 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
N425021018510followed by a unit qualifier and the quantityPackage 25021-0185-10. 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 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 is indicated for the…
Excerpt only. Read the full label for complete information.
About NDC 25021-185
- What is NDC 25021-185?
- 25021-185 is the product NDC for ganciclovir (ganciclovir sodium), Ganciclovir sodium 50 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. 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?
- Sagent Pharmaceuticals, NDC labeler code 25021. 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 |
| Ganciclovir | Ganciclovir sodium 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Par Health USA, LLC | 42023-173 | 42023-0173-25 |
| Ganciclovirganciclovir sodium | Ganciclovir sodium 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-315 | 63323-0315-94 |
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 500 mg/10mL | Injection, SolutionIntravenous | Pharmascience Inc. | 51817-171 |