What is NDC 72205-019?

72205-019 is the product NDC for valganciclovir hydrochloride, Valganciclovir hydrochloride 50 mg/mL for solution, listed with the FDA by Novadoz Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

valganciclovir hydrochloride NDC 72205-019

NDC codes

FDA NDC Directory

Product NDC (as listed)72205-019Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72205-0019Add 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
72205-019-01	7220500190172205001901	1 BOTTLE in 1 CARTON (72205-019-01) / 100 mL in 1 BOTTLEMarketed from Sep 14, 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 hydrochloride
Active ingredients: Valganciclovir hydrochloride — 50 mg/mL
Dosage form: For solution
Route: Oral
Labeler: Novadoz Pharmaceuticals LLCNDC labeler code 72205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210169
Marketing start: Feb 17, 2022
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 72205-019_614ff447-7e5f-4ea6-ba85-ec1f6497b360SPL ID 614ff447-7e5f-4ea6-ba85-ec1f6497b360SPL set ID 614ff447-7e5f-4ea6-ba85-ec1f6497b360RxCUI 863559UNII 4P3T9QF9NZUPC 0372205019010
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

N472205001901 followed by a unit qualifier and the quantity

Package 72205-0019-01. 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 Jan 29, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Valganciclovir 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 for oral solution is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [ see Clinical Studies (14.1) ] . Prevention of CMV Disease : Valgancicl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72205-019

What is NDC 72205-019?: 72205-019 is the product NDC for valganciclovir hydrochloride, Valganciclovir hydrochloride 50 mg/mL for solution, listed with the FDA by Novadoz Pharmaceuticals 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?: Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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.

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

Other valganciclovir hydrochloride NDCs
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 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 210169

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210169
Product	Strength	Form · route	Labeler	Product NDC
Valganciclovir	Valganciclovir hydrochloride 50 mg/mL	For solutionOral	airis PHARMA PVT LTD	71151-003