NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8904Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8904Add 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
68788-8904-36878889040330 TABLET, FILM COATED in 1 BOTTLE (68788-8904-3)Marketed from Jul 31, 2025
68788-8904-96878889040990 TABLET, FILM COATED in 1 BOTTLE (68788-8904-9)Marketed from Jul 31, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
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 68788-8904_82ddec27-79ac-40f4-afde-707f3940f893SPL ID 82ddec27-79ac-40f4-afde-707f3940f893SPL set ID 82ddec27-79ac-40f4-afde-707f3940f893RxCUI 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

N468788890403 followed by a unit qualifier and the quantity

Package 68788-8904-03. 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 o Treatment in immunocompetent patients (initial or recurrent episode) o Suppression in immunocompetent or HIV-1-infected patients o 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 f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8904

What is NDC 68788-8904?
68788-8904 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 2 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 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 HydrochloridevalacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-848268788-8482-0368788-8482-09
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
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1TabletOralTIME CAP LABORATORIES, INC.49483-69149483-0691-0149483-0691-0349483-0691-04+1 more

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 1 g/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4728
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4727
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 coatedOralProficient Rx LP63187-776
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
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-042
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-043
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralA-S Medication Solutions50090-1173
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralProficient Rx LP82804-093
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4885
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralProficient Rx LP63187-832
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0708
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralRedpharm Drug67296-2293
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralAvPAK50268-788
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralAsclemed USA, Inc.76420-600
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralAvPAK50268-789

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