posaconazole
- Product NDC
- 68462-911
- 11-digit product format
- 684620911
- Labeler code
- 68462
- Product ID
- 68462-911_5ad94bba-fba7-4e3e-809c-6e51ad7a5930
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- posaconazole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA217553
- Marketing category
- ANDA
- Marketing start
- 2024-07-01
- Substance
- POSACONAZOLE
- Active strength
- 18 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- posaconazole
- Listing expiration
- 2027-12-31
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 |
|---|
| 68462-911-01 | posaconazole | 16.7 mL in 1 VIAL | INJECTION, SOLUTION | 16.7 | | 2 |
| 68462-911-01 | posaconazole | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-911 | POSACONAZOLE INJECTION, SOLUTION [GLENMARK PHARMACEUTICALS INC., USA] | 1 | Current NDC, 2 package rows | 20240805_91f89a3b-2479-4d05-9997-7b0cfaa496ec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68462-911-01 | 68462091101 | 1 VIAL in 1 CARTON (68462-911-01) / 16.7 mL in 1 VIAL | 1 vial | 2024-07-01 | No | No | Current |