Valacyclovir NDC 63304-905

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-905Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0905Add 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
63304-905-03	63304090503	10 TABLET, FILM COATED in 1 BOTTLE (63304-905-03)Marketed from Dec 19, 2020
63304-905-05	63304090505	500 TABLET, FILM COATED in 1 BOTTLE (63304-905-05)Marketed from Dec 19, 2020
63304-905-77	63304090577	100 BLISTER PACK in 1 CARTON (63304-905-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (63304-905-11)Marketed from Dec 19, 2020
63304-905-90	63304090590	90 TABLET, FILM COATED in 1 BOTTLE (63304-905-90)Marketed from Dec 19, 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): Valacyclovir
Generic name (nonproprietary): valacyclovir
Active ingredients: Valacyclovir hydrochloride — 1 g/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: SUN PHARMACEUTICAL INDUSTRIES, INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076588
Marketing start: Dec 19, 2020
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 63304-905_536bdec7-e486-ae91-e063-6294a90a0ed7SPL ID 536bdec7-e486-ae91-e063-6294a90a0ed7SPL set ID 26634bf1-c6d8-4d48-9a4e-845c47df07f8RxCUI 313564, 313565UNII G447S0T1VCUPC 0363304905304, 0363304904307
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

N463304090503 followed by a unit qualifier and the quantity

Package 63304-0905-03. 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 Jun 4, 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 076588

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

FDA NDC Directory listings under ANDA 076588
Product	Strength	Form · route	Labeler	Product NDC
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-107
Valacyclovir	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-108
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-031
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	SUN PHARMACEUTICAL INDUSTRIES, INC.	63304-904