NDC codes

FDA NDC Directory
Product NDC (as listed)27241-159Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27241-0159Add 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
27241-159-1927241015919272410159191 POUCH in 1 CARTON (27241-159-19) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLEMarketed from Jan 13, 2020

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
Powder, For solution
Route
Oral
Labeler
Ajanta Pharma USA Inc.NDC labeler code 27241
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212890
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 27241-159_6f6211f4-3501-4957-92a1-bd68f2962203SPL ID 6f6211f4-3501-4957-92a1-bd68f2962203SPL set ID 178a014b-92c7-44a7-abb8-95d89a2feb8fRxCUI 863559UNII 4P3T9QF9NZUPC 0327241159190
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

N427241015919 followed by a unit qualifier and the quantity

Package 27241-0159-19. 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 . 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 tablets, USP 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 27241-159

What is NDC 27241-159?
27241-159 is the product NDC for Valganciclovir hydrochloride, Valganciclovir hydrochloride 50 mg/mL powder, for solution, listed with the FDA by Ajanta Pharma USA Inc.. 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?
Ajanta Pharma USA Inc., NDC labeler code 27241. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Valganciclovir HydrochlorideValganciclovir hydrochloride 450 mg/1TabletOralNorthStar Rx LLC72603-75072603-0750-01
valganciclovir hydrochlorideValganciclovir hydrochloride 50 mg/mLFor solutionOralNovadoz Pharmaceuticals LLC72205-01972205-0019-01
Valganciclovir HydrochloridevalganciclovirValganciclovir 50 mg/mLFor solutionOralSomerset Therapeutics, LLC70069-81070069-0810-01
Valganciclovir HydrochloridevalganciclovirValganciclovir 50 mg/mLFor solutionOralGranules Pharmaceuticals Inc.70010-05170010-0051-40
valganciclovir hydrochlorideValganciclovir hydrochloride 450 mg/1TabletOralDr. Reddy's Laboratories Inc43598-35643598-0356-3043598-0356-60
Valganciclovir HydrochlorideValganciclovir hydrochloride 450 mg/1TabletOralAurobindo Pharma Limited65862-75365862-0753-0165862-0753-0565862-0753-18+2 more

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