Prescription drug · NDA
Valtrex (Valacyclovir hydrochloride) NDC 0173-0933
Valacyclovir hydrochloride 500 mg/1 · Tablet, Film coated · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0933-08 | 00173093308 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0933-08)Marketed from Aug 1, 1995 | |
| 0173-0933-10 | 00173093310 | 90 TABLET, FILM COATED in 1 BOTTLE (0173-0933-10)Marketed from Aug 1, 1995 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Valtrex
- Generic name (nonproprietary)
- valacyclovir hydrochloride
- Active ingredients
- Valacyclovir hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020487
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 0173-0933_861c5801-9c12-4a6b-9bf4-aacb183a58b0SPL ID 861c5801-9c12-4a6b-9bf4-aacb183a58b0SPL set ID f8e0d8f8-cb73-4206-a484-88f5c4fbd719RxCUI 108780, 212448, 313564, 313565UNII G447S0T1VCUPC 0301730933089
- 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
N400173093308followed by a unit qualifier and the quantityPackage 00173-0933-08. 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)
VALTREX 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 VALTREX 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) VALTREX is indicated for treatment of cold sores (herpes labia…
Excerpt only. Read the full label for complete information.
About NDC 0173-0933
- What is NDC 0173-0933?
- 0173-0933 is the product NDC for Valtrex (valacyclovir hydrochloride), Valacyclovir hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by GlaxoSmithKline LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valtrex (Valacyclovir hydrochloride).
- What is the active ingredient?
- Valacyclovir hydrochloride.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valtrex?
- 2 other product NDCs are listed under this name. See all Valtrex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Valtrex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Valtrexvalacyclovir hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2039 | 70518-2039-0170518-2039-02 |
| Valtrexvalacyclovir hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0565 | 00173-0565-0400173-0565-10 |
Other NDCs under NDA 020487
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Valtrexvalacyclovir hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0565 |
| Valtrexvalacyclovir hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2039 |