NDC codes

FDA NDC Directory
Product NDC (as listed)61919-066Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61919-0066Add 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
61919-066-20619190066206191900662020 TABLET, FILM COATED in 1 BOTTLE (61919-066-20)Marketed from Jan 1, 2015
61919-066-60619190066606191900666060 TABLET, FILM COATED in 1 BOTTLE (61919-066-60)Marketed from Jan 1, 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)
Valacyclovir
Generic name (nonproprietary)
valacyclovir
Active ingredients
Valacyclovir hydrochloride — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Direct RxNDC labeler code 61919
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201506
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 61919-066_364a2f8b-adfa-b8ce-e063-6394a90a8f9dSPL ID 364a2f8b-adfa-b8ce-e063-6394a90a8f9dSPL set ID cbd7bb49-7a9c-4383-a158-bfc307db0130RxCUI 313565UNII G447S0T1VC
Pharmacologic class
Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor

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

N461919006620 followed by a unit qualifier and the quantity

Package 61919-0066-20. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE SECTION 1.1 Adult Patients Cold Sores (Herpes Labialis): Valacyclovir Tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir hydrochloride initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes: Initial Episode: Valacyclovir Tablets, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir Tablets, USP are indic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61919-066

What is NDC 61919-066?
61919-066 is the product NDC for Valacyclovir, Valacyclovir hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Direct Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Valacyclovir.
What is the active ingredient?
Valacyclovir hydrochloride.
Who is the labeler?
Direct Rx, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Valacyclovir?
53 other product NDCs are listed under this name. See all Valacyclovir 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 Valacyclovir NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-85660760-0856-42
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralREMEDYREPACK INC.70518-466170518-4661-00
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralCoupler LLC67046-134767046-1347-03
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralCoupler LLC67046-107167046-1071-03
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-410568788-4105-0368788-4105-09
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-441770518-4417-00
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralDirect_Rx72189-63072189-0630-2072189-0630-30
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralDirect _Rx72189-59472189-0594-0472189-0594-1672189-0594-21+1 more
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-870568788-8705-0068788-8705-0168788-8705-02+4 more
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralREMEDYREPACK INC.70518-410070518-4100-0070518-4100-0170518-4100-02+5 more

All 54 Valacyclovir NDCs

Other NDCs under ANDA 201506

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

FDA NDC Directory listings under ANDA 201506
ProductStrengthForm · routeLabelerProduct NDC
valacyclovir hydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralJubilant Cadista Pharmaceuticals Inc.59746-324
valacyclovir hydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralJubilant Cadista Pharmaceuticals Inc.59746-325
valacyclovir hydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralProficient Rx LP63187-538

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in