Prescription drug · ANDA
Valganciclovir Hydrochloride NDC 72603-750
Valganciclovir hydrochloride 450 mg/1 · Tablet · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-750-01 | 7260307500172603075001 | 60 TABLET in 1 BOTTLE (72603-750-01)Marketed from Mar 1, 2026 |
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 hydrochloride
- Active ingredients
- Valganciclovir hydrochloride — 450 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NorthStar Rx LLCNDC labeler code 72603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204750
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 72603-750_1cc09039-dcd6-4721-abd4-411535ccf442SPL ID 1cc09039-dcd6-4721-abd4-411535ccf442SPL set ID 1cc09039-dcd6-4721-abd4-411535ccf442RxCUI 313566UNII 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
N472603075001followed by a unit qualifier and the quantityPackage 72603-0750-01. 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 tablets are 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: Valganciclovi…
Excerpt only. Read the full label for complete information.
About NDC 72603-750
- What is NDC 72603-750?
- 72603-750 is the product NDC for Valganciclovir Hydrochloride, Valganciclovir hydrochloride 450 mg/1 tablet, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valganciclovir Hydrochloride.
- What is the active ingredient?
- Valganciclovir hydrochloride.
- Who is the labeler?
- NorthStar Rx LLC, NDC labeler code 72603. 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 50 mg/mL | For solutionOral | Novadoz Pharmaceuticals LLC | 72205-019 | 72205-0019-01 |
| Valganciclovir Hydrochloridevalganciclovir | Valganciclovir 50 mg/mL | For solutionOral | Somerset Therapeutics, LLC | 70069-810 | 70069-0810-01 |
| 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 204750
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 | Valganciclovir hydrochloride 450 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-753 |