NDC codes

FDA NDC Directory
Product NDC (as listed)57237-043Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0043Add 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
57237-043-0557237004305500 TABLET, FILM COATED in 1 BOTTLE (57237-043-05)Marketed from May 24, 2010
57237-043-305723700433030 TABLET, FILM COATED in 1 BOTTLE (57237-043-30)Marketed from May 24, 2010
57237-043-905723700439090 TABLET, FILM COATED in 1 BOTTLE (57237-043-90)Marketed from May 24, 2010

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 Hydrochloride
Generic name (nonproprietary)
valacyclovir hydrochloride
Active ingredients
Valacyclovir hydrochloride — 1 g/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 57237
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 57237-043_a9ee543a-9c63-46df-99f9-cd085ce08beeSPL ID a9ee543a-9c63-46df-99f9-cd085ce08beeSPL set ID 8d1645c0-fd03-4992-9372-98026a26b3afRxCUI 313564, 313565UNII G447S0T1VCUPC 0357237043301
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

N457237004305 followed by a unit qualifier and the quantity

Package 57237-0043-05. 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 57237-043

What is NDC 57237-043?
57237-043 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 1 g/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 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?
Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 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 coatedOralAmerican Health Packaging68084-215
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6565
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-730
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-263
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-264
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralAmerican Health Packaging68084-309
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthStar Rx LLC16714-697
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-698
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2266
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8820
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralBryant Ranch Prepack71335-1862
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-757
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralSportpharm LLC85766-026
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4727
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3359
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4728
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralProficient Rx LP63187-776
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralSportpharm LLC85766-054
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-633
Valacyclovir HydrochlorideValacyclovir hydrochloride 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4783

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