Prescription drug · ANDA
Valacyclovir Hydrochloride NDC 60760-757
Valacyclovir hydrochloride 1 g/1 · Tablet, Film coated · Oral · St. Mary's Medical Park Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60760-757-42 | 60760075742 | 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-757-42)Marketed from Nov 14, 2024 |
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
- 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 60760-757_54e3a918-287d-e7c6-e063-6294a90af66fSPL ID 54e3a918-287d-e7c6-e063-6294a90af66fSPL set ID 275c0198-10a5-139e-e063-6394a90a72beRxCUI 313564UNII 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
N460760075742followed by a unit qualifier and the quantityPackage 60760-0757-42. 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.
Other NDCs under ANDA 090682
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 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7985 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-697 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-215 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-698 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6565 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | American Health Packaging | 68084-309 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-026 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8820 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2266 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1862 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-054 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4727 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4728 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-633 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-776 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-448 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-449 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3359 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4783 |
| Valacyclovir Hydrochloride | Valacyclovir hydrochloride 1 g/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-703 |
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