Valacyclovir Hydrochloride
- Product NDC
- 72789-264
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valacyclovir Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090682
- Marketing category
- ANDA
- Substance
- VALACYCLOVIR HYDROCHLORIDE
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 72789-264-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-264-30) | 2022-07-22 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 | PD-Rx Pharmaceuticals, Inc. | 2026-02-25 | HUMAN PRESCRIPTION DRUG LABEL | 20 |
| These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 | PD-Rx Pharmaceuticals, Inc. | 2024-04-25 | HUMAN PRESCRIPTION DRUG LABEL | 18 |