Voriconazole
- Product NDC
- 31722-224
- 11-digit product format
- 317220224
- Labeler code
- 31722
- Product ID
- 31722-224_4f5284da-5bb9-2f61-e063-6294a90ab0ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Voriconazole
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA218533
- Marketing category
- ANDA
- Marketing start
- 2024-04-03
- Substance
- VORICONAZOLE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Voriconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VORICONAZOLE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JFU09I87TR |
| Rxcui | 351209 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-224-31 | Voriconazole | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 3 |
| 31722-224-31 | Voriconazole | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-224 | VORICONAZOLE (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20240511_fff10d69-e334-42bd-baed-7d9d5feef6aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-224-31 | 31722022431 | 1 VIAL, SINGLE-DOSE in 1 CARTON (31722-224-31) / 20 mL in 1 VIAL, SINGLE-DOSE | 2024-04-03 | No | No | Historical |