Valacyclovir NDC 87063-349

Product information

Brand name (proprietary)

Valacyclovir

Generic name (nonproprietary)

valacyclovir

Active ingredients

Valacyclovir hydrochloride — 500 mg/1

Dosage form

Tablet

Route

Oral

Labeler

ASCLEMED USA INC.NDC labeler code 87063

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 87063-349_5d9f1c0a-4f7a-1e82-e063-6294a90accadSPL ID 5d9f1c0a-4f7a-1e82-e063-6294a90accad

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

N487063034902 followed by a unit qualifier and the quantity Copy

Package 87063-0349-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 87063-349

What is NDC 87063-349?

87063-349 is the product NDC for Valacyclovir, Valacyclovir hydrochloride 500 mg/1 tablet, listed with the FDA by ASCLEMED USA INC.. It has 12 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?

ASCLEMED USA INC., NDC labeler code 87063. 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.

Related NDCs: other Valacyclovir products

Other finished products listed under the same name: strengths, forms and labelers.

All 54 Valacyclovir NDCs

Other NDCs under ANDA 209553

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

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