Prescription drug · ANDA
Valacyclovir NDC 61919-066
Valacyclovir hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Direct Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-066-20 | 61919006620 | 20 TABLET, FILM COATED in 1 BOTTLE (61919-066-20)Marketed from Jan 1, 2015 | |
| 61919-066-60 | 61919006660 | 60 TABLET, FILM COATED in 1 BOTTLE (61919-066-60)Marketed from Jan 1, 2015 |
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
- Generic name (nonproprietary)
- valacyclovir
- Active ingredients
- Valacyclovir hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201506
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 61919-066_364a2f8b-adfa-b8ce-e063-6394a90a8f9dSPL ID 364a2f8b-adfa-b8ce-e063-6394a90a8f9dSPL set ID cbd7bb49-7a9c-4383-a158-bfc307db0130RxCUI 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
N461919006620followed by a unit qualifier and the quantityPackage 61919-0066-20. 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)
INDICATIONS AND USAGE SECTION 1.1 Adult Patients Cold Sores (Herpes Labialis): Valacyclovir Tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir hydrochloride initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes: Initial Episode: Valacyclovir Tablets, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir Tablets, USP are indic…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201506
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 |
|---|---|---|---|---|
| valacyclovir hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-325 |
| valacyclovir hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-324 |
| valacyclovir hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-538 |