Prescription drug · ANDA

Valacyclovir (Valacyclovir hydrochloride) NDC 69117-0011

Valacyclovir hydrochloride 1 g/1 · Tablet · Oral · Yiling Pharmaceutical, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)69117-0011Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69117-0011Add 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
69117-0011-16911700110130 TABLET in 1 BOTTLE (69117-0011-1)Marketed from Oct 1, 2018
69117-0011-26911700110290 TABLET in 1 BOTTLE (69117-0011-2)Marketed from Oct 1, 2018
69117-0011-369117001103500 TABLET in 1 BOTTLE (69117-0011-3)Marketed from Oct 1, 2018

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 hydrochloride
Active ingredients
Valacyclovir hydrochloride — 1 g/1
Dosage form
Tablet
Route
Oral
Labeler
Yiling Pharmaceutical, Inc.NDC labeler code 69117
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 69117-0011_47237b45-ce93-292b-e063-6394a90a1ab5SPL ID 47237b45-ce93-292b-e063-6394a90a1ab5SPL set ID f3ee4017-a4fc-475d-a49b-b39168ec5966RxCUI 313564, 313565UNII G447S0T1VCUPC 0369117001011, 0369117001127, 0369117001110, 0369117001134
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

N469117001101 followed by a unit qualifier and the quantity

Package 69117-0011-01. 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 tablets are 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 69117-0011

What is NDC 69117-0011?
69117-0011 is the product NDC for Valacyclovir (valacyclovir hydrochloride), Valacyclovir hydrochloride 1 g/1 tablet, listed with the FDA by Yiling Pharmaceutical, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Valacyclovir (Valacyclovir Hydrochloride).
What is the active ingredient?
Valacyclovir hydrochloride.
Who is the labeler?
Yiling Pharmaceutical, Inc., NDC labeler code 69117. 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?
51 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 52 Valacyclovir NDCs

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 500 mg/1TabletOralA-S Medication Solutions50090-6581
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralA-S Medication Solutions50090-7270
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralA-S Medication Solutions50090-7484
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-856
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralChartwell RX, LLC62135-613
ValacyclovirValacyclovir hydrochloride 1 g/1TabletOralChartwell RX, LLC62135-614
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralRedpharm Drug67296-2146
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3624
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4105
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8705
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralYiling Pharmaceutical, Inc.69117-0010
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralWestminster Pharmaceuticals, LLC69367-262
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralWestminster Pharmaceuticals, LLC69367-263
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralREMEDYREPACK INC.70518-4100
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralREMEDYREPACK INC.70518-4661
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralBryant Ranch Prepack71335-2534
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-2566
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralDirect _Rx72189-594
ValacyclovirValacyclovir hydrochloride 500 mg/1TabletOralDirect_Rx72189-630
ValacyclovirValacyclovir hydrochloride 1000 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-586

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