What is NDC 42571-477?

42571-477 is the product NDC for Valganciclovir, Valganciclovir hydrochloride 50 mg/mL powder, for solution, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Micro Labs Limited, NDC labeler code 42571. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valganciclovir NDC 42571-477 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-477Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0477Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42571-477-47	4257104774742571047747	1 BOTTLE in 1 CARTON (42571-477-47) / 100 mL in 1 BOTTLEMarketed from Jun 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
Generic name (nonproprietary): valganciclovir
Active ingredients: Valganciclovir hydrochloride — 50 mg/mL
Dosage form: Powder, For solution
Route: Oral
Labeler: Micro Labs LimitedNDC labeler code 42571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218838
Marketing start: Jun 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 42571-477_4dab410e-74c6-a8bc-e063-6394a90a03f4SPL ID 4dab410e-74c6-a8bc-e063-6394a90a03f4SPL set ID facbcc41-52cf-4433-b3fc-9bf8f06dcdd9RxCUI 863559UNII 4P3T9QF9NZUPC 0342571477479
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

N442571047747 followed by a unit qualifier and the quantity

Package 42571-0477-47. 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 Mar 23, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Valganciclovir 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 for oral solution 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.

Full label on DailyMed (opens in a new tab)

About NDC 42571-477

What is NDC 42571-477?: 42571-477 is the product NDC for Valganciclovir, Valganciclovir hydrochloride 50 mg/mL powder, for solution, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Valganciclovir.
What is the active ingredient?: Valganciclovir hydrochloride.
Who is the labeler?: Micro Labs Limited, NDC labeler code 42571. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Valganciclovir NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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 powder,	Valganciclovir hydrochloride 50 mg/mL	For solutionOral	Aurobindo Pharma Limited	59651-444	59651-0444-01
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

All 16 Valganciclovir NDCs