Valacyclovir Hydrochloride
- Product NDC
- 68788-8820
- 11-digit product format
- 687888820
- Labeler code
- 68788
- Product ID
- 68788-8820_52ea1a06-965e-476f-bb5b-e672b50102ea
- 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
- 2025-01-23
- Substance
- VALACYCLOVIR HYDROCHLORIDE
- Active strength
- 1 g/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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Valacyclovir Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| VALACYCLOVIR HYDROCHLORIDE | 1 g/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | G447S0T1VC |
| Rxcui | 313564 |
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 |
|---|
| 68788-8820-0 | 68788882000 | 6 TABLET, FILM COATED in 1 BOTTLE (68788-8820-0) | 2025-01-23 | No | No | Current |
| 68788-8820-1 | 68788882001 | 10 TABLET, FILM COATED in 1 BOTTLE (68788-8820-1) | 2025-01-23 | No | No | Current |
| 68788-8820-2 | 68788882002 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8820-2) | 2025-01-23 | No | No | Current |
| 68788-8820-3 | 68788882003 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8820-3) | 2025-01-23 | No | No | Current |
| 68788-8820-4 | 68788882004 | 4 TABLET, FILM COATED in 1 BOTTLE (68788-8820-4) | 2025-01-23 | No | No | Current |
| 68788-8820-5 | 68788882005 | 15 TABLET, FILM COATED in 1 BOTTLE (68788-8820-5) | 2025-01-23 | No | No | Current |
| 68788-8820-7 | 68788882007 | 21 TABLET, FILM COATED in 1 BOTTLE (68788-8820-7) | 2025-01-23 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Valacyclovir Hydrochloride | Preferred Pharmaceuticals Inc. | 2025-02-03 | HUMAN PRESCRIPTION DRUG LABEL | 2 |