Posaconazole
- Product NDC
- 63323-685
- 11-digit product format
- 633230685
- Labeler code
- 63323
- Product ID
- 63323-685_3ed81dc8-a1e0-4513-be2a-7a16aea62198
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Posaconazole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresensius Kabi USA, LLC
- Application
- ANDA209983
- Marketing category
- ANDA
- Marketing start
- 2023-12-26
- Substance
- POSACONAZOLE
- Active strength
- 18 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Posaconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POSACONAZOLE | 18 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6TK1G07BHZ |
| Rxcui | 1492043 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-685-17 | Posaconazole | 16.7 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 16.7 | | 1 |
| 63323-685-17 | Posaconazole | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-685 | POSACONAZOLE INJECTION, SOLUTION [FRESENSIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20240104_86be8cdb-c991-4754-b8f4-1ab79ac40bda.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63323-685-17 | 63323068517 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-685-17) / 16.7 mL in 1 VIAL, SINGLE-DOSE | 2023-12-26 | No | No | Current |