Prescription drug · NDA
Valcyte (Valganciclovir) NDC 61269-480
Valganciclovir hydrochloride 450 mg/1 · Tablet, Film coated · Oral · H2-Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-480-60 | 6126904806061269048060 | 1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 29, 2001 |
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)
- Valcyte
- Generic name (nonproprietary)
- valganciclovir
- Active ingredients
- Valganciclovir hydrochloride — 450 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- H2-Pharma, LLCNDC labeler code 61269
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021304
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 61269-480_c70cbfa5-6b69-4fd4-8ad0-e819c8795746SPL ID c70cbfa5-6b69-4fd4-8ad0-e819c8795746SPL set ID 4c517a39-2ded-4c5a-8d56-276853414b31RxCUI 284587, 313566, 863559, 863562UNII 4P3T9QF9NZ
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461269048060followed by a unit qualifier and the quantityPackage 61269-0480-60. 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)
VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients ( 1.2 ) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1) ] . Prevention of CMV Disease: VALCYTE is indicated for the prevention of CM…
Excerpt only. Read the full label for complete information.
About NDC 61269-480
- What is NDC 61269-480?
- 61269-480 is the product NDC for Valcyte (valganciclovir), Valganciclovir hydrochloride 450 mg/1 tablet, film coated, listed with the FDA by H2-Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valcyte (Valganciclovir).
- What is the active ingredient?
- Valganciclovir hydrochloride.
- Who is the labeler?
- H2-Pharma, LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valcyte?
- 1 other product NDC are listed under this name. See all Valcyte NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valcyte products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valcytevalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | H2-Pharma, LLC | 61269-485 | 61269-0485-10 |