NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7587Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7587Add 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
68788-7587-068788758700687887587006 TABLET, FILM COATED in 1 BOTTLE (68788-7587-0)Marketed from Dec 27, 2019
68788-7587-1687887587016878875870110 TABLET, FILM COATED in 1 BOTTLE (68788-7587-1)Marketed from Dec 27, 2019
68788-7587-2687887587026878875870220 TABLET, FILM COATED in 1 BOTTLE (68788-7587-2)Marketed from Dec 27, 2019
68788-7587-3687887587036878875870330 TABLET, FILM COATED in 1 BOTTLE (68788-7587-3)Marketed from Dec 27, 2019
68788-7587-468788758704687887587044 TABLET, FILM COATED in 1 BOTTLE (68788-7587-4)Marketed from Dec 27, 2019
68788-7587-5687887587056878875870515 TABLET, FILM COATED in 1 BOTTLE (68788-7587-5)Marketed from Dec 27, 2019
68788-7587-7687887587076878875870721 TABLET, FILM COATED in 1 BOTTLE (68788-7587-7)Marketed from Dec 27, 2019

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
Generic name (nonproprietary)
valacyclovir
Active ingredients
Valacyclovir hydrochloride — 1 g/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 203047
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 68788-7587_c347cba6-fba8-4c16-9584-c79d6c2a8179SPL ID c347cba6-fba8-4c16-9584-c79d6c2a8179SPL set ID 7abc96b9-8f34-4fda-b5bb-1bdf23c1e135RxCUI 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

N468788758700 followed by a unit qualifier and the quantity

Package 68788-7587-00. 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 tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( ) • 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 ( ) • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use ( ) 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-7587

What is NDC 68788-7587?
68788-7587 is the product NDC for Valacyclovir, Valacyclovir hydrochloride 1 g/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 7 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?
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?
53 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-85660760-0856-42
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralREMEDYREPACK INC.70518-466170518-4661-00
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralCoupler LLC67046-134767046-1347-03
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralCoupler LLC67046-107167046-1071-03
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-410568788-4105-0368788-4105-09
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-441770518-4417-00
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralDirect_Rx72189-63072189-0630-2072189-0630-30
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralDirect _Rx72189-59472189-0594-0472189-0594-1672189-0594-21+1 more
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-870568788-8705-0068788-8705-0168788-8705-02+4 more
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralREMEDYREPACK INC.70518-410070518-4100-0070518-4100-0170518-4100-02+5 more

All 54 Valacyclovir NDCs

Other NDCs under ANDA 203047

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

FDA NDC Directory listings under ANDA 203047
ProductStrengthForm · routeLabelerProduct NDC
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-704
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-705
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-771
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2510
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralA-S Medication Solutions50090-2575
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7702
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralSt Mary's Medical Park Pharmacy60760-469
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralProficient Rx LP63187-950
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralCoupler LLC67046-1071
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralCoupler LLC67046-1347
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3747
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3749
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4805
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2402
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4417
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralBryant Ranch Prepack71335-0630
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-452
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-040
ValacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-041
ValacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralProficient Rx LP82804-212

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