Prescription drug · ANDA
Valganciclovir (Valganciclovir hydrochloride powder,) NDC 59651-444
Valganciclovir hydrochloride 50 mg/mL · For solution · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-444-01 | 5965104440159651044401 | 1 BOTTLE, GLASS in 1 CARTON (59651-444-01) / 100 mL in 1 BOTTLE, GLASSMarketed from Nov 17, 2022 |
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
- Generic name (nonproprietary)
- valganciclovir hydrochloride powder,
- Active ingredients
- Valganciclovir hydrochloride — 50 mg/mL
- Dosage form
- For solution
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215124
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 59651-444_a1e3ad22-5bc8-45a1-9a9b-1305533be169SPL ID a1e3ad22-5bc8-45a1-9a9b-1305533be169SPL set ID 1e08a87f-624a-4993-a773-8c660c27b6afRxCUI 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
N459651044401followed by a unit qualifier and the quantityPackage 59651-0444-01. 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 hydrochloride 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: Valganciclovir tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)]. Prevention of CMV Disease: Valganciclo…
Excerpt only. Read the full label for complete information.
About NDC 59651-444
- What is NDC 59651-444?
- 59651-444 is the product NDC for Valganciclovir, Valganciclovir hydrochloride 50 mg/mL for solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valganciclovir (Valganciclovir hydrochloride powder,).
- What is the active ingredient?
- Valganciclovir hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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?
- 15 other product NDCs are listed under this name. See all Valganciclovir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valganciclovir 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 | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | Micro Labs Limited | 42571-477 | 42571-0477-47 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 450 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-161 | 64380-0161-01 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | NorthStar RxLLC | 72603-174 | 72603-0174-01 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 450 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-973 | 42291-0973-60 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | American Health Packaging | 60687-765 | 60687-0765-13 |
| Valganciclovir | Valganciclovir 50 mg/mL | Powder, For solutionOral | Florida Pharmaceutical Products, LLC | 71921-210 | 71921-0210-12 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | Camber Pharmaceuticals, Inc. | 31722-837 | 31722-0837-10 |
| Valganciclovirvalganciclovir hydrochloride | Valganciclovir hydrochloride 450 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-153 | 64380-0153-01 |
| Valganciclovir | Valganciclovir hydrochloride 50 mg/mL | For solutionOral | airis PHARMA PVT LTD | 71151-003 | 71151-0003-01 |
| Valganciclovir | Valganciclovir hydrochloride 450 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-158 | 27241-0158-60 |