Posaconazole
- Product NDC
- 42023-195
- 11-digit product format
- 420230195
- Labeler code
- 42023
- Product ID
- 42023-195_70da1db2-5881-462d-86c6-04adaac2c630
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Posaconazole
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Par Health USA, LLC
- Application
- ANDA208768
- Marketing category
- ANDA
- Marketing start
- 2023-01-01
- 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 |
|---|
| 42023-195-01 | Posaconazole | 1 in 1 CARTON | INJECTION | 1 | | 20 |
| 42023-195-01 | Posaconazole | 16.7 mL in 1 VIAL, GLASS | INJECTION | 16.7 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-195 | POSACONAZOLE INJECTION [ENDO USA, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240425_4032672e-1bb0-427d-a3b3-09cda4beaf34.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42023-195-01 | 42023019501 | 1 VIAL, GLASS in 1 CARTON (42023-195-01) / 16.7 mL in 1 VIAL, GLASS | 2023-01-01 | 0000-00-00 | No | No | Current |