What is NDC 63187-538?

63187-538 is the product NDC for valacyclovir hydrochloride, Valacyclovir hydrochloride 1 g/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. 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 hydrochloride?

56 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

valacyclovir hydrochloride NDC 63187-538

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-538Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0538Add 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
63187-538-04	6318705380463187053804	4 TABLET, FILM COATED in 1 BOTTLE (63187-538-04)Marketed from Sep 1, 2015
63187-538-14	6318705381463187053814	14 TABLET, FILM COATED in 1 BOTTLE (63187-538-14)Marketed from Sep 1, 2015
63187-538-30	6318705383063187053830	30 TABLET, FILM COATED in 1 BOTTLE (63187-538-30)Marketed from Sep 1, 2015
63187-538-60	6318705386063187053860	60 TABLET, FILM COATED in 1 BOTTLE (63187-538-60)Marketed from Sep 1, 2015
63187-538-90	6318705389063187053890	90 TABLET, FILM COATED in 1 BOTTLE (63187-538-90)Marketed from Sep 1, 2015

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
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201506
Marketing start: Apr 5, 2012
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 63187-538_0ac3f14c-c375-408e-a1d7-8412e3420a40SPL ID 0ac3f14c-c375-408e-a1d7-8412e3420a40SPL set ID efe37bd1-a236-43cc-828c-b57e8a704d67RxCUI 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

N463187053804 followed by a unit qualifier and the quantity

Package 63187-0538-04. 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 Jan 1, 2020.

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 hydrochloride 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-538

What is NDC 63187-538?: 63187-538 is the product NDC for valacyclovir hydrochloride, Valacyclovir hydrochloride 1 g/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: valacyclovir hydrochloride.
What is the active ingredient?: Valacyclovir hydrochloride.
Who is the labeler?: Proficient Rx LP, NDC labeler code 63187. 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 hydrochloride?: 56 other product NDCs are listed under this name. See all valacyclovir hydrochloride 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 hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-117	82868-0117-21
Valacyclovir Hydrochloridevalacyclovir	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-106	82868-0106-21
Valacyclovir Hydrochloridevalacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-144	48433-0144-03
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8904	68788-8904-0368788-8904-09
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8820	68788-8820-0068788-8820-0168788-8820-02+4 more
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-757	60760-0757-42
Valacyclovir Hydrochloridevalacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-055	82868-0055-21
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-703	51655-0703-0451655-0703-2151655-0703-53
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-633	51655-0633-2151655-0633-84
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3359	70518-3359-0170518-3359-0270518-3359-03

All 57 valacyclovir hydrochloride NDCs

Other NDCs under ANDA 201506

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

FDA NDC Directory listings under ANDA 201506
Product	Strength	Form · route	Labeler	Product NDC
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Direct Rx	61919-066
valacyclovir hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-324
valacyclovir hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-325