Valacyclovir
- Product NDC
- 71335-2534
- 11-digit product format
- 713352534
- Labeler code
- 71335
- Product ID
- 71335-2534_415566e0-337e-421f-81ae-313f9f33c05c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valacyclovir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209553
- Marketing category
- ANDA
- Marketing start
- 2023-02-14
- Substance
- VALACYCLOVIR HYDROCHLORIDE
- Active strength
- 1000 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
openFDA Listing Details
- Product ID
- 71335-2534_415566e0-337e-421f-81ae-313f9f33c05c
- SPL ID
- 415566e0-337e-421f-81ae-313f9f33c05c
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Valacyclovir
- Generic name
- Valacyclovir
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2023-02-14
- Marketing category
- ANDA
- Application number
- ANDA209553
- 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]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| VALACYCLOVIR HYDROCHLORIDE | 1000 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | G447S0T1VC |
| Rxcui | 313564 |
| Spl Set Id | b713ebfb-096e-445e-ab15-129aca20fadf |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2534-0 | 60 TABLET in 1 BOTTLE (71335-2534-0) | 2024-12-10 | No |
| 71335-2534-1 | 30 TABLET in 1 BOTTLE (71335-2534-1) | 2024-12-10 | No |
| 71335-2534-2 | 21 TABLET in 1 BOTTLE (71335-2534-2) | 2024-12-10 | No |
| 71335-2534-3 | 20 TABLET in 1 BOTTLE (71335-2534-3) | 2024-12-10 | No |
| 71335-2534-4 | 4 TABLET in 1 BOTTLE (71335-2534-4) | 2024-12-10 | No |
| 71335-2534-5 | 10 TABLET in 1 BOTTLE (71335-2534-5) | 2024-12-10 | No |
| 71335-2534-6 | 6 TABLET in 1 BOTTLE (71335-2534-6) | 2024-12-10 | No |
| 71335-2534-7 | 15 TABLET in 1 BOTTLE (71335-2534-7) | 2024-12-10 | No |
| 71335-2534-8 | 8 TABLET in 1 BOTTLE (71335-2534-8) | 2024-12-10 | No |
| 71335-2534-9 | 90 TABLET in 1 BOTTLE (71335-2534-9) | 2024-12-10 | No |
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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2534-0 | 71335253400 | 60 TABLET in 1 BOTTLE (71335-2534-0) | 60 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-1 | 71335253401 | 30 TABLET in 1 BOTTLE (71335-2534-1) | 30 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-2 | 71335253402 | 21 TABLET in 1 BOTTLE (71335-2534-2) | 21 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-3 | 71335253403 | 20 TABLET in 1 BOTTLE (71335-2534-3) | 20 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-4 | 71335253404 | 4 TABLET in 1 BOTTLE (71335-2534-4) | 4 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-5 | 71335253405 | 10 TABLET in 1 BOTTLE (71335-2534-5) | 10 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-6 | 71335253406 | 6 TABLET in 1 BOTTLE (71335-2534-6) | 6 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-7 | 71335253407 | 15 TABLET in 1 BOTTLE (71335-2534-7) | 15 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-8 | 71335253408 | 8 TABLET in 1 BOTTLE (71335-2534-8) | 8 tablet | 2024-12-10 | No | No | Historical |
| 71335-2534-9 | 71335253409 | 90 TABLET in 1 BOTTLE (71335-2534-9) | 90 tablet | 2024-12-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Valacyclovir | Bryant Ranch Prepack | 2024-12-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |