What is NDC 68084-965?

68084-965 is the product NDC for Valganciclovir, Valganciclovir hydrochloride 450 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. It has 2 package NDCs, shown above in 10- and 11-digit form.

American Health Packaging, NDC labeler code 68084. 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 68084-965 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68084-965Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68084-0965Add 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
68084-965-19	6808409651968084096519	20 BLISTER PACK in 1 CARTON (68084-965-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18)Marketed from Nov 6, 2024
68084-965-25	6808409652568084096525	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-965-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-95)Marketed from Jan 16, 2015

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 — 450 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: American Health PackagingNDC labeler code 68084
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203511
Marketing start: Jan 16, 2015
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 68084-965_55015e34-52fc-0309-e063-6394a90af0f9SPL ID 55015e34-52fc-0309-e063-6394a90af0f9SPL set ID 4db6dd63-e56b-45a4-86b2-ee125a1854a0RxCUI 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

N468084096519 followed by a unit qualifier and the quantity

Package 68084-0965-19. 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 Jun 24, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Valganciclovir tablet 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: Valganciclovir table…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68084-965

What is NDC 68084-965?: 68084-965 is the product NDC for Valganciclovir, Valganciclovir hydrochloride 450 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. It has 2 package NDCs, 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?: American Health Packaging, NDC labeler code 68084. 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)
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 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

All 16 Valganciclovir NDCs

Other NDCs under ANDA 203511

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

FDA NDC Directory listings under ANDA 203511
Product	Strength	Form · route	Labeler	Product NDC
Valganciclovir	Valganciclovir hydrochloride 450 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Limited	55111-762