What is NDC 65862-448?

65862-448 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. 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 65862-448

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-448Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0448Add 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
65862-448-01	6586204480165862044801	100 TABLET, FILM COATED in 1 BOTTLE (65862-448-01)Marketed from May 24, 2010
65862-448-05	6586204480565862044805	500 TABLET, FILM COATED in 1 BOTTLE (65862-448-05)Marketed from May 24, 2010
65862-448-10	6586204481065862044810	10 BLISTER PACK in 1 CARTON (65862-448-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 24, 2010
65862-448-30	6586204483065862044830	30 TABLET, FILM COATED in 1 BOTTLE (65862-448-30)Marketed from May 24, 2010
65862-448-35	6586204483565862044835	3500 TABLET, FILM COATED in 1 BOTTLE (65862-448-35)Marketed from May 24, 2010
65862-448-90	6586204489065862044890	90 TABLET, FILM COATED in 1 BOTTLE (65862-448-90)Marketed from May 24, 2010

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 — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090682
Marketing start: May 24, 2010
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 65862-448_aecf12c1-9094-48b6-8cb0-fcace52e191aSPL ID aecf12c1-9094-48b6-8cb0-fcace52e191aSPL set ID f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5RxCUI 313564, 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

N465862044801 followed by a unit qualifier and the quantity

Package 65862-0448-01. 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 Dec 4, 2025.

Indications (excerpt from the label)

Valacyclovir hydrochloride is 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 o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-448

What is NDC 65862-448?: 65862-448 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 6 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?: Aurobindo Pharma Limited, NDC labeler code 65862. 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 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
Product	Strength	Form · route	Labeler	Product NDC
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0708
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-117
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-600
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2366
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-7985
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Proficient Rx LP	82804-093
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8820
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-215
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2266
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-757
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6565
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Sportpharm LLC	85766-026
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	American Health Packaging	68084-309
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1173
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4727
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4728
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-633
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-263
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-449
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-264

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