NDC codes

FDA NDC Directory
Product NDC (as listed)85766-054Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85766-0054Add 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
85766-054-018576600540185766005401100 TABLET, FILM COATED in 1 BOTTLE (85766-054-01)Marketed from Aug 17, 2025
85766-054-0285766005402857660054022 TABLET, FILM COATED in 1 BOTTLE (85766-054-02)Marketed from Aug 17, 2025
85766-054-0485766005404857660054044 TABLET, FILM COATED in 1 BOTTLE (85766-054-04)Marketed from Aug 17, 2025
85766-054-0785766005407857660054077 TABLET, FILM COATED in 1 BOTTLE (85766-054-07)Marketed from Aug 17, 2025
85766-054-10857660054108576600541010 TABLET, FILM COATED in 1 BOTTLE (85766-054-10)Marketed from Aug 17, 2025
85766-054-14857660054148576600541414 TABLET, FILM COATED in 1 BOTTLE (85766-054-14)Marketed from Aug 17, 2025
85766-054-15857660054158576600541515 TABLET, FILM COATED in 1 BOTTLE (85766-054-15)Marketed from Aug 17, 2025
85766-054-20857660054208576600542020 TABLET, FILM COATED in 1 BOTTLE (85766-054-20)Marketed from Aug 17, 2025
85766-054-28857660054288576600542828 TABLET, FILM COATED in 1 BOTTLE (85766-054-28)Marketed from Oct 23, 2025
85766-054-30857660054308576600543030 TABLET, FILM COATED in 1 BOTTLE (85766-054-30)Marketed from Aug 17, 2025
85766-054-60857660054608576600546060 TABLET, FILM COATED in 1 BOTTLE (85766-054-60)Marketed from Aug 17, 2025
85766-054-90857660054908576600549090 TABLET, FILM COATED in 1 BOTTLE (85766-054-90)Marketed from Aug 17, 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 Hydrochloride
Generic name (nonproprietary)
valacyclovir hydrochloride
Active ingredients
Valacyclovir hydrochloride — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Sportpharm LLCNDC labeler code 85766
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 85766-054_502ee215-ab84-3c2c-e063-6294a90a2f73SPL ID 502ee215-ab84-3c2c-e063-6294a90a2f73SPL set ID 7681a6f4-a6e7-4277-adbd-38837d5ead6bRxCUI 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

N485766005401 followed by a unit qualifier and the quantity

Package 85766-0054-01. 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 .

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 of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85766-054

What is NDC 85766-054?
85766-054 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Sportpharm LLC. It has 12 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?
Sportpharm LLC, NDC labeler code 85766. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-11782868-0117-21
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-10682868-0106-21
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralSafecor Health LLC48433-14448433-0144-03
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-890468788-8904-0368788-8904-09
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-882068788-8820-0068788-8820-0168788-8820-02+4 more
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-75760760-0757-42
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-05582868-0055-21
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-70351655-0703-0451655-0703-2151655-0703-53
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-63351655-0633-2151655-0633-84
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralREMEDYREPACK INC.70518-335970518-3359-0170518-3359-0270518-3359-03

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
ProductStrengthForm · routeLabelerProduct NDC
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0708
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-117
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralAsclemed USA, Inc.76420-600
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2366
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7985
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralProficient Rx LP82804-093
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8820
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-215
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 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6565
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralSportpharm LLC85766-026
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralAmerican Health Packaging68084-309
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralA-S Medication Solutions50090-1173
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 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-263
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralAurobindo Pharma Limited65862-449

Showing 20 of 39.

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