NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6796Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6796Add 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 NDC11-digit (billing)PackageCopy
0904-6796-04009046796040090467960430 BLISTER PACK in 1 CARTON (0904-6796-04) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 18, 2016
0904-6796-10009046796100090467961020 BLISTER PACK in 1 CARTON (0904-6796-10) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 18, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205166
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 0904-6796_d77110cf-ef90-4565-a751-8ebedc10c2aaSPL ID d77110cf-ef90-4565-a751-8ebedc10c2aaSPL set ID 6a6533fd-0579-4059-ba87-aa399829a8b0RxCUI 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

N400904679604 followed by a unit qualifier and the quantity

Package 00904-6796-04. 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: Valganci…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6796

What is NDC 0904-6796?
0904-6796 is the product NDC for Valganciclovir, Valganciclovir hydrochloride 450 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. 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?
Major Pharmaceuticals, NDC labeler code 0904. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ValganciclovirValganciclovir hydrochloride 50 mg/mLPowder, For solutionOralMicro Labs Limited42571-47742571-0477-47
Valganciclovirvalganciclovir hydrochlorideValganciclovir hydrochloride 450 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-16164380-0161-01
Valganciclovirvalganciclovir hydrochlorideValganciclovir hydrochloride 50 mg/mLPowder, For solutionOralNorthStar RxLLC72603-17472603-0174-01
Valganciclovirvalganciclovir hydrochlorideValganciclovir hydrochloride 450 mg/1Tablet, Film coatedOralAvKARE42291-97342291-0973-60
Valganciclovirvalganciclovir hydrochlorideValganciclovir hydrochloride 50 mg/mLPowder, For solutionOralAmerican Health Packaging60687-76560687-0765-13
ValganciclovirValganciclovir 50 mg/mLPowder, For solutionOralFlorida Pharmaceutical Products, LLC71921-21071921-0210-12
Valganciclovirvalganciclovir hydrochloride powder,Valganciclovir hydrochloride 50 mg/mLFor solutionOralAurobindo Pharma Limited59651-44459651-0444-01
Valganciclovirvalganciclovir hydrochlorideValganciclovir hydrochloride 50 mg/mLPowder, For solutionOralCamber Pharmaceuticals, Inc.31722-83731722-0837-10
Valganciclovirvalganciclovir hydrochlorideValganciclovir hydrochloride 450 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-15364380-0153-01
ValganciclovirValganciclovir hydrochloride 50 mg/mLFor solutionOralairis PHARMA PVT LTD71151-00371151-0003-01

All 16 Valganciclovir NDCs

Other NDCs under ANDA 205166

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

FDA NDC Directory listings under ANDA 205166
ProductStrengthForm · routeLabelerProduct NDC
ValganciclovirValganciclovir hydrochloride 450 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-832
ValganciclovirValganciclovir hydrochloride 450 mg/1Tablet, Film coatedOralAvPAK50268-787

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