Prescription drug · NDA
Valtrex (Valacyclovir hydrochloride) NDC 70518-2039
Valacyclovir hydrochloride 1 g/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2039-1 | 7051820390170518203901 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-1)Marketed from Jul 17, 2023 | |
| 70518-2039-2 | 7051820390270518203902 | 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2039-2)Marketed from Oct 2, 2023 |
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)
- Valtrex
- Generic name (nonproprietary)
- valacyclovir hydrochloride
- Active ingredients
- Valacyclovir hydrochloride — 1 g/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-2039_5d17e1fe-3e7c-5dca-e063-6394a90a7a90SPL ID 5d17e1fe-3e7c-5dca-e063-6394a90a7a90
- 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
N470518203901followed by a unit qualifier and the quantityPackage 70518-2039-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-2039
- What is NDC 70518-2039?
- 70518-2039 is the product NDC for Valtrex (valacyclovir hydrochloride), Valacyclovir hydrochloride 1 g/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | GlaxoSmithKline LLC | 0173-0565 | 00173-0565-0400173-0565-10 |
| Valtrexvalacyclovir hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0933 | 00173-0933-0800173-0933-10 |
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 500 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0933 |