Prescription drug · ANDA
Valganciclovir Hydrochloride (Valganciclovir) NDC 70069-810
Valganciclovir 50 mg/mL · For solution · Oral · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-810-01 | 7006908100170069081001 | 100 mL in 1 BOTTLE (70069-810-01)Marketed from Jan 15, 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 Hydrochloride
- Generic name (nonproprietary)
- valganciclovir
- Active ingredients
- Valganciclovir — 50 mg/mL
- Dosage form
- For solution
- Route
- Oral
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213306
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 70069-810_48f8965d-d9ca-7c96-e063-6394a90af350SPL ID 48f8965d-d9ca-7c96-e063-6394a90af350SPL set ID b856bfaf-ec6b-4171-81c4-b9b07f780084RxCUI 863559UNII GCU97FKN3RUPC 0370069810019
- Pharmacologic class
- Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
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
N470069081001followed by a unit qualifier and the quantityPackage 70069-0810-01. 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)
N/A 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 hydrochloride is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)] . Prevention of CMV Diseas…
Excerpt only. Read the full label for complete information.
About NDC 70069-810
- What is NDC 70069-810?
- 70069-810 is the product NDC for Valganciclovir Hydrochloride (valganciclovir), Valganciclovir 50 mg/mL for solution, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valganciclovir Hydrochloride (Valganciclovir).
- What is the active ingredient?
- Valganciclovir.
- Who is the labeler?
- Somerset Therapeutics, LLC, NDC labeler code 70069. 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?
- 6 other product NDCs are listed under this name. See all Valganciclovir Hydrochloride 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 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 | Valganciclovir hydrochloride 450 mg/1 | TabletOral | NorthStar Rx LLC | 72603-750 | 72603-0750-01 |
| valganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | For solutionOral | Novadoz Pharmaceuticals LLC | 72205-019 | 72205-0019-01 |
| Valganciclovir Hydrochloridevalganciclovir | Valganciclovir 50 mg/mL | For solutionOral | Granules Pharmaceuticals Inc. | 70010-051 | 70010-0051-40 |
| Valganciclovir hydrochloride | Valganciclovir hydrochloride 50 mg/mL | Powder, For solutionOral | Ajanta Pharma USA Inc. | 27241-159 | 27241-0159-19 |
| valganciclovir hydrochloride | Valganciclovir hydrochloride 450 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc | 43598-356 | 43598-0356-3043598-0356-60 |
| Valganciclovir Hydrochloride | Valganciclovir hydrochloride 450 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-753 | 65862-0753-0165862-0753-0565862-0753-18+2 more |
Other NDCs under ANDA 213306
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 Hydrochloridevalganciclovir | Valganciclovir 50 mg/mL | For solutionOral | Granules Pharmaceuticals Inc. | 70010-051 |