Valacyclovir NDC 69367-263

NDC codes

FDA NDC Directory

Product NDC (as listed)69367-263Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69367-0263Add 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 NDC	11-digit (billing)	Package	Copy
69367-263-09	69367026309	90 TABLET in 1 BOTTLE (69367-263-09)Marketed from Feb 14, 2023
69367-263-30	69367026330	30 TABLET in 1 BOTTLE (69367-263-30)Marketed from Feb 14, 2023

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 — 1000 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Westminster Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209553
Marketing start: Feb 14, 2023
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 69367-263_0d49baa9-8b27-4d4c-b57a-802a337565f9SPL ID 0d49baa9-8b27-4d4c-b57a-802a337565f9SPL set ID 4bd97421-1e0a-40a6-a66b-f5f14e827eb3RxCUI 313564, 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

N469367026309 followed by a unit qualifier and the quantity

Package 69367-0263-09. 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 May 11, 2026.

Indications (excerpt from the label)

Valacyclovir tablets are 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 for treatment of…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209553

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

FDA NDC Directory listings under ANDA 209553
Product	Strength	Form · route	Labeler	Product NDC
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3624
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Redpharm Drug	67296-2146
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-586
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Chartwell RX, LLC	62135-613
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-856
Valacyclovir	Valacyclovir hydrochloride 1 g/1	TabletOral	Chartwell RX, LLC	62135-614
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7484
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Proficient Rx LP	82804-009
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Proficient Rx LP	82804-006
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Sportpharm LLC	85766-271
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Sportpharm LLC	85766-270
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4105
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-6581
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	REMEDYREPACK INC.	70518-4100
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Bryant Ranch Prepack	71335-2534
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8705
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7270
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Direct _Rx	72189-594
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-262
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-2566

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