NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0630Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0630Add 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
71335-0630-0713350630007133506300060 TABLET, FILM COATED in 1 BOTTLE (71335-0630-0)Marketed from Oct 5, 2021
71335-0630-1713350630017133506300130 TABLET, FILM COATED in 1 BOTTLE (71335-0630-1)Marketed from May 29, 2018
71335-0630-2713350630027133506300221 TABLET, FILM COATED in 1 BOTTLE (71335-0630-2)Marketed from Mar 21, 2018
71335-0630-3713350630037133506300320 TABLET, FILM COATED in 1 BOTTLE (71335-0630-3)Marketed from Jul 24, 2018
71335-0630-471335063004713350630044 TABLET, FILM COATED in 1 BOTTLE (71335-0630-4)Marketed from Jul 13, 2018
71335-0630-5713350630057133506300510 TABLET, FILM COATED in 1 BOTTLE (71335-0630-5)Marketed from May 28, 2019
71335-0630-671335063006713350630066 TABLET, FILM COATED in 1 BOTTLE (71335-0630-6)Marketed from Mar 20, 2018
71335-0630-7713350630077133506300715 TABLET, FILM COATED in 1 BOTTLE (71335-0630-7)Marketed from Mar 4, 2019
71335-0630-871335063008713350630088 TABLET, FILM COATED in 1 BOTTLE (71335-0630-8)Marketed from May 29, 2018
71335-0630-9713350630097133506300990 TABLET, FILM COATED in 1 BOTTLE (71335-0630-9)Marketed from Feb 18, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1 g/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203047
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 71335-0630_375e88d9-f545-4d58-bad6-f0281802d93cSPL ID 375e88d9-f545-4d58-bad6-f0281802d93cSPL set ID e5f5223f-569c-40c6-a3c7-381bc61cf8c6RxCUI 313564UNII 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

N471335063000 followed by a unit qualifier and the quantity

Package 71335-0630-00. 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)

Valacyclovir tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment in immunocompetent patients (initial or recurrent episode) • Suppression in immunocompetent or HIV-1-infected patients • Reduction of transmission • Herpes Zoster Pediatric Patients ( 1.2 ) • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use ( 1.3 ) The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0630

What is NDC 71335-0630?
71335-0630 is the product NDC for Valacyclovir, Valacyclovir hydrochloride 1 g/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 203047

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

FDA NDC Directory listings under ANDA 203047
ProductStrengthForm · routeLabelerProduct NDC
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-704
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-705
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-771
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2510
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralA-S Medication Solutions50090-2575
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7702
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralSt Mary's Medical Park Pharmacy60760-469
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralProficient Rx LP63187-950
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralCoupler LLC67046-1071
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralCoupler LLC67046-1347
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3747
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3749
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4805
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7587
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2402
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4417
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-452
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-040
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-041
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralProficient Rx LP82804-212

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