NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1341Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1341Add 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
71335-1341-07133513410060 TABLET, FILM COATED in 1 BOTTLE (71335-1341-0)Marketed from Nov 8, 2019
71335-1341-17133513410115 TABLET, FILM COATED in 1 BOTTLE (71335-1341-1)Marketed from Apr 23, 2021
71335-1341-27133513410210 TABLET, FILM COATED in 1 BOTTLE (71335-1341-2)Marketed from Sep 13, 2019
71335-1341-3713351341034 TABLET, FILM COATED in 1 BOTTLE (71335-1341-3)Marketed from Dec 28, 2021
71335-1341-4713351341047 TABLET, FILM COATED in 1 BOTTLE (71335-1341-4)Marketed from Sep 4, 2020
71335-1341-57133513410520 TABLET, FILM COATED in 1 BOTTLE (71335-1341-5)Marketed from May 22, 2020
71335-1341-67133513410630 TABLET, FILM COATED in 1 BOTTLE (71335-1341-6)Marketed from Sep 12, 2019
71335-1341-7713351341078 TABLET, FILM COATED in 1 BOTTLE (71335-1341-7)Marketed from Jan 16, 2020
71335-1341-87133513410890 TABLET, FILM COATED in 1 BOTTLE (71335-1341-8)Marketed from Dec 28, 2021
71335-1341-97133513410914 TABLET, FILM COATED in 1 BOTTLE (71335-1341-9)Marketed from Feb 4, 2020

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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078518
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 71335-1341_cfe4b984-62e1-4984-8717-7559cac30c15SPL ID cfe4b984-62e1-4984-8717-7559cac30c15SPL set ID c28c069f-3b51-4474-aa38-1aed6b7b8678RxCUI 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

N471335134100 followed by a unit qualifier and the quantity

Package 71335-1341-00. 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 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1341

What is NDC 71335-1341?
71335-1341 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 500 mg/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 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 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

All 57 Valacyclovir Hydrochloride NDCs

Other NDCs under ANDA 078518

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

FDA NDC Directory listings under ANDA 078518
ProductStrengthForm · routeLabelerProduct NDC
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-4275
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-4276
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralSafecor Health LLC48433-144
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralMylan Institutional Inc.51079-093
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-2127
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8482
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0541
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-055
Valacyclovir HydrochloridevalacyclovirValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-106

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