NDC codes

FDA NDC Directory
Product NDC (as listed)31722-832Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0832Add 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
31722-832-31317220832313172208323110 TABLET, FILM COATED in 1 BLISTER PACK (31722-832-31)Marketed from Mar 18, 2016
31722-832-32317220832323172208323210 TABLET, FILM COATED in 1 CARTON (31722-832-32)Marketed from Mar 18, 2016
31722-832-60317220832603172208326060 TABLET, FILM COATED in 1 BOTTLE (31722-832-60)Marketed from Mar 18, 2016

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
Camber Pharmaceuticals, Inc.NDC labeler code 31722
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 31722-832_2b44d151-5b10-9250-e063-6294a90a53c2SPL ID 2b44d151-5b10-9250-e063-6294a90a53c2SPL set ID 383e8810-b877-4a4f-abdf-c8c4c8e394f8RxCUI 313566UNII 4P3T9QF9NZUPC 0331722832601
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

N431722083231 followed by a unit qualifier and the quantity

Package 31722-0832-31. 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 31722-832

What is NDC 31722-832?
31722-832 is the product NDC for Valganciclovir, Valganciclovir hydrochloride 450 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 3 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?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 coatedOralMajor Pharmaceuticals0904-6796
ValganciclovirValganciclovir hydrochloride 450 mg/1Tablet, Film coatedOralAvPAK50268-787

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