Prescription drug · ANDA

Valacyclovir NDC 82804-009

Valacyclovir hydrochloride 500 mg/1 · Tablet · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)82804-009Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0009Add 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
82804-009-06828040009066 TABLET in 1 BOTTLE (82804-009-06)Marketed from Sep 13, 2023
82804-009-108280400091010 TABLET in 1 BOTTLE (82804-009-10)Marketed from Dec 26, 2023
82804-009-218280400092121 TABLET in 1 BOTTLE (82804-009-21)Marketed from Sep 13, 2023
82804-009-308280400093030 TABLET in 1 BOTTLE (82804-009-30)Marketed from Sep 13, 2023
82804-009-608280400096060 TABLET in 1 BOTTLE (82804-009-60)Marketed from Sep 13, 2023
82804-009-908280400099090 TABLET in 1 BOTTLE (82804-009-90)Marketed from Sep 13, 2023

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209553
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 82804-009_dcd80515-07e5-476c-b923-22bb48af61f3SPL ID dcd80515-07e5-476c-b923-22bb48af61f3SPL set ID a3a6a874-f568-429d-96b4-8ef89393564fRxCUI 313564, 313565UNII G447S0T1VCUPC 0382804006212, 0382804009060
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

N482804000906 followed by a unit qualifier and the quantity

Package 82804-0009-06. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
ProductStrengthForm · routeLabelerProduct NDC
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3624
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralRedpharm Drug67296-2146
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-586
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralChartwell RX, LLC62135-613
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-856
ValacyclovirValacyclovir hydrochloride 1 g/1TabletOralChartwell RX, LLC62135-614
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralA-S Medication Solutions50090-7484
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralProficient Rx LP82804-006
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralSportpharm LLC85766-271
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralSportpharm LLC85766-270
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4105
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-6581
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralREMEDYREPACK INC.70518-4100
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralBryant Ranch Prepack71335-2534
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8705
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralA-S Medication Solutions50090-7270
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralDirect _Rx72189-594
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralWestminster Pharmaceuticals, LLC69367-262
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralWestminster Pharmaceuticals, LLC69367-263
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-2566

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