posaconazole
- Product NDC
- 67457-665
- 11-digit product format
- 674570665
- Labeler code
- 67457
- Product ID
- 67457-665_834e282d-211e-4896-9be0-76e83f960859
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- posaconazole
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA211500
- Marketing category
- ANDA
- Marketing start
- 2024-03-22
- 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 |
|---|
| 67457-665-20 | posaconazole | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 67457-665-20 | posaconazole | 16.7 mL in 1 VIAL, GLASS | SOLUTION | 16.7 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-665 | POSACONAZOLE SOLUTION [MYLAN INSTITUTIONAL LLC] | 2 | Current NDC, 2 package rows | 20241218_1ebbd88b-547b-4b49-ab73-98094a2d5a79.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67457-665-20 | 67457066520 | 1 VIAL, GLASS in 1 CARTON (67457-665-20) / 16.7 mL in 1 VIAL, GLASS | 2024-03-22 | No | No | Current |