Prescription drug · ANDA

Valacyclovir Hydrochloride NDC 63187-776

Valacyclovir hydrochloride 1 g/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-776Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0776Add 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
63187-776-04631870776044 TABLET, FILM COATED in 1 BOTTLE (63187-776-04)Marketed from Dec 1, 2016
63187-776-106318707761010 TABLET, FILM COATED in 1 BOTTLE (63187-776-10)Marketed from Nov 21, 2019
63187-776-146318707761414 TABLET, FILM COATED in 1 BOTTLE (63187-776-14)Marketed from Nov 21, 2019
63187-776-206318707762020 TABLET, FILM COATED in 1 BOTTLE (63187-776-20)Marketed from Feb 5, 2020
63187-776-216318707762121 TABLET, FILM COATED in 1 BOTTLE (63187-776-21)Marketed from Nov 1, 2016
63187-776-306318707763030 TABLET, FILM COATED in 1 BOTTLE (63187-776-30)Marketed from Nov 1, 2016
63187-776-606318707766060 TABLET, FILM COATED in 1 BOTTLE (63187-776-60)Marketed from Nov 1, 2016
63187-776-906318707769090 TABLET, FILM COATED in 1 BOTTLE (63187-776-90)Marketed from Nov 1, 2016

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 Hydrochloride
Generic name (nonproprietary)
valacyclovir hydrochloride
Active ingredients
Valacyclovir hydrochloride — 1 g/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090682
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 63187-776_e5dca408-5050-47da-a6c8-fb75a79cc86eSPL ID e5dca408-5050-47da-a6c8-fb75a79cc86eSPL set ID 268af320-810a-48de-9a08-9850be2878e3RxCUI 313564UNII G447S0T1VCUPC 0363187776213
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

N463187077604 followed by a unit qualifier and the quantity

Package 63187-0776-04. 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 hydrochloride is a nucleoside 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-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, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090682

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

FDA NDC Directory listings under ANDA 090682
ProductStrengthForm · routeLabelerProduct NDC
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7985
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthStar Rx LLC16714-697
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-215
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-698
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6565
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralAmerican Health Packaging68084-309
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralSportpharm LLC85766-026
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8820
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2266
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-757
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralBryant Ranch Prepack71335-1862
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralSportpharm LLC85766-054
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4727
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4728
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-633
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-448
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralAurobindo Pharma Limited65862-449
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3359
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4783
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-703

Showing 20 of 39.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in