NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1862Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1862Add 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
71335-1862-0713351862007133518620060 TABLET, FILM COATED in 1 BOTTLE (71335-1862-0)Marketed from Oct 21, 2021
71335-1862-1713351862017133518620130 TABLET, FILM COATED in 1 BOTTLE (71335-1862-1)Marketed from Oct 21, 2021
71335-1862-2713351862027133518620221 TABLET, FILM COATED in 1 BOTTLE (71335-1862-2)Marketed from Oct 21, 2021
71335-1862-3713351862037133518620320 TABLET, FILM COATED in 1 BOTTLE (71335-1862-3)Marketed from Oct 21, 2021
71335-1862-471335186204713351862044 TABLET, FILM COATED in 1 BOTTLE (71335-1862-4)Marketed from Oct 21, 2021
71335-1862-5713351862057133518620510 TABLET, FILM COATED in 1 BOTTLE (71335-1862-5)Marketed from Oct 21, 2021
71335-1862-671335186206713351862066 TABLET, FILM COATED in 1 BOTTLE (71335-1862-6)Marketed from Oct 21, 2021
71335-1862-7713351862077133518620715 TABLET, FILM COATED in 1 BOTTLE (71335-1862-7)Marketed from Oct 21, 2021
71335-1862-871335186208713351862088 TABLET, FILM COATED in 1 BOTTLE (71335-1862-8)Marketed from Oct 21, 2021
71335-1862-9713351862097133518620990 TABLET, FILM COATED in 1 BOTTLE (71335-1862-9)Marketed from Oct 21, 2021

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 — 1 g/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-1862_18d8f022-a73f-4704-85b0-d9cafc35e035SPL ID 18d8f022-a73f-4704-85b0-d9cafc35e035SPL set ID 4619bcc6-0070-4f3b-9cf9-900f3e5f7b19RxCUI 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

N471335186200 followed by a unit qualifier and the quantity

Package 71335-1862-00. 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 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 71335-1862

What is NDC 71335-1862?
71335-1862 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 1 g/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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

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