VALGANCICLOVIR HYDROCHLORIDE
- Product NDC
- 70010-051
- 11-digit product format
- 700100051
- Labeler code
- 70010
- Product ID
- 70010-051_1292e397-2837-b544-e063-6394a90a229b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VALGANCICLOVIR
- Dosage form
- FOR SOLUTION
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA213306
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- Substance
- VALGANCICLOVIR
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], 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
- VALGANCICLOVIR HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VALGANCICLOVIR | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GCU97FKN3R |
| Rxcui | 863559 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70010-051-40 | VALGANCICLOVIR HYDROCHLORIDE | 100 mL in 1 BOTTLE | FOR SOLUTION | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-051 | VALGANCICLOVIR HYDROCHLORIDE (VALGANCICLOVIR) FOR SOLUTION [GRANULES PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20240302_39452b74-161d-4525-a0f7-fe486f001513.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70010-051-40 | 70010005140 | 100 mL in 1 BOTTLE (70010-051-40) | 100 ml | 2021-07-01 | 0000-00-00 | No | No | Current |