Valacyclovir
- Product NDC
- 68071-3747
- 11-digit product format
- 680713747
- Labeler code
- 68071
- Product ID
- 68071-3747_3c43a66b-174e-3a76-e063-6394a90a03a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valacyclovir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA203047
- Marketing category
- ANDA
- Marketing start
- 2015-05-25
- Substance
- VALACYCLOVIR HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| G447S0T1VC | VALACYCLOVIR HYDROCHLORIDE | 124832-27-5 | VALACYCLOVIR HYDROCHLORIDE |
| MZ1IW7Q79D | VALACYCLOVIR | 124832-26-4 | Valacyclovir |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3747-3 | 68071374703 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3747-3) | 2024-12-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Valacyclovir | NuCare Pharmaceuticals, Inc. | 2025-08-13 | HUMAN PRESCRIPTION DRUG LABEL | 2 |