What is NDC 72189-630?

72189-630 is the product NDC for Valacyclovir, Valacyclovir hydrochloride 500 mg/1 tablet, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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?

51 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valacyclovir NDC 72189-630 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-630Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0630Add 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
72189-630-20	72189063020	20 TABLET in 1 BOTTLE (72189-630-20)Marketed from Jun 26, 2025
72189-630-30	72189063030	20 TABLET in 1 BOTTLE (72189-630-30)Marketed from Jun 26, 2025

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 — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209553
Marketing start: Jun 26, 2025
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 72189-630_3c6c3546-b4a4-1f0e-e063-6394a90a8c29SPL ID 3c6c3546-b4a4-1f0e-e063-6394a90a8c29SPL set ID 387c9c12-4735-1f9d-e063-6394a90a030cRxCUI 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

N472189063020 followed by a unit qualifier and the quantity

Package 72189-0630-20. 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 Aug 15, 2025.

Indications (excerpt from the label)

1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes Initial Episode: Valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets are indicated for treatment of recurrent episodes of genital herpes …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-630

What is NDC 72189-630?: 72189-630 is the product NDC for Valacyclovir, Valacyclovir hydrochloride 500 mg/1 tablet, listed with the FDA by Direct_Rx. It has 2 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?: Direct_Rx, NDC labeler code 72189. 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?: 51 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.

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

Other Valacyclovir NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-856	60760-0856-42
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4661	70518-4661-00
Valacyclovir	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Coupler LLC	67046-1347	67046-1347-03
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1071	67046-1071-03
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4105	68788-4105-0368788-4105-09
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4417	70518-4417-00
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Direct _Rx	72189-594	72189-0594-0472189-0594-1672189-0594-21+1 more
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8705	68788-8705-0068788-8705-0168788-8705-02+4 more
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	REMEDYREPACK INC.	70518-4100	70518-4100-0070518-4100-0170518-4100-02+5 more
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-6581	50090-6581-0050090-6581-0150090-6581-02+1 more

All 52 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.

FDA NDC Directory listings under ANDA 209553
Product	Strength	Form · route	Labeler	Product NDC
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-6581
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7270
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7484
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-856
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Chartwell RX, LLC	62135-613
Valacyclovir	Valacyclovir hydrochloride 1 g/1	TabletOral	Chartwell RX, LLC	62135-614
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Redpharm Drug	67296-2146
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3624
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4105
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8705
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Yiling Pharmaceutical, Inc.	69117-0010
Valacyclovirvalacyclovir hydrochloride	Valacyclovir hydrochloride 1 g/1	TabletOral	Yiling Pharmaceutical, Inc.	69117-0011
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-262
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-263
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	REMEDYREPACK INC.	70518-4100
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4661
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Bryant Ranch Prepack	71335-2534
Valacyclovir	Valacyclovir hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-2566
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	Direct _Rx	72189-594
Valacyclovir	Valacyclovir hydrochloride 1000 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-586

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