Valacyclovir Hydrochloride
- Product NDC
- 68788-8904
- 11-digit product format
- 687888904
- Labeler code
- 68788
- Product ID
- 68788-8904_82ddec27-79ac-40f4-afde-707f3940f893
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valacyclovir Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090682
- Marketing category
- ANDA
- Marketing start
- 2025-07-31
- 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 |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8904-3 | 68788890403 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8904-3) | 2025-07-31 | No | No | Historical |
| 68788-8904-9 | 68788890409 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8904-9) | 2025-07-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Valacyclovir Hydrochloride | Preferred Pharmaceuticals Inc. | 2025-07-31 | HUMAN PRESCRIPTION DRUG LABEL | 1 |