Prescription drug · ANDA
Valganciclovir hydrochloride for Oral (Valganciclovir hydrochloride) NDC 42291-972
Valganciclovir hydrochloride 50 mg/mL · Powder, For solution · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-972-01 | 4229109720142291097201 | 100 mL in 1 BOTTLE (42291-972-01)Marketed from Oct 17, 2023 |
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)
- Valganciclovir hydrochloride for Oral
- Generic name (nonproprietary)
- valganciclovir hydrochloride
- Active ingredients
- Valganciclovir hydrochloride — 50 mg/mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205220
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 42291-972_48c2d3e0-cf43-2438-e063-6294a90a9557SPL ID 48c2d3e0-cf43-2438-e063-6294a90a9557SPL set ID 07eb5abf-2322-4fb9-e063-6394a90a2311RxCUI 863559UNII 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
N442291097201followed by a unit qualifier and the quantityPackage 42291-0972-01. 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)
Valganciclovir for oral solution is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Pediatric Patients ( 1.2 ) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.2 Pediatric Patients Prevention of CMV Disease: Valganciclovir is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies ( 14.2 )] .
Excerpt only. Read the full label for complete information.
About NDC 42291-972
- What is NDC 42291-972?
- 42291-972 is the product NDC for Valganciclovir hydrochloride for Oral, Valganciclovir hydrochloride 50 mg/mL powder, for solution, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valganciclovir hydrochloride for Oral (Valganciclovir hydrochloride).
- What is the active ingredient?
- Valganciclovir hydrochloride.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valganciclovir hydrochloride for Oral?
- 1 other product NDC are listed under this name. See all Valganciclovir hydrochloride for Oral NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valganciclovir hydrochloride for Oral products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valganciclovir hydrochloride for Oralvalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | Actavis Pharma, Inc. | 0591-2579 | 00591-2579-20 |
Other NDCs under ANDA 205220
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 |
|---|---|---|---|---|
| Valganciclovir hydrochloride for Oralvalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | Actavis Pharma, Inc. | 0591-2579 |