POSACONAZOLE
- Product NDC
- 0254-1016
- 11-digit product format
- 002541016
- Labeler code
- 0254
- Product ID
- 0254-1016_15fdf050-71cb-476f-a7ce-38c40262f381
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- posaconazole
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ENDO USA, Inc.
- Application
- NDA022003
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-03-29
- Substance
- POSACONAZOLE
- Active strength
- 40 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 | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6TK1G07BHZ |
| Rxcui | 665019, 1482908 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0254-1016-36 | POSACONAZOLE | 1 in 1 CARTON | SUSPENSION | 1 | | 15 |
| 0254-1016-36 | POSACONAZOLE | 105 mL in 1 BOTTLE, GLASS | SUSPENSION | 105 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0254-1016 | POSACONAZOLE TABLET, COATED POSACONAZOLE SUSPENSION [ENDO USA, INC.] | 13 | Current NDC, 2 package rows | 20240829_e031b632-8e57-4359-87bd-a5da02bdc55f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0254-1016-36 | 00254101636 | 1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS | 2023-03-29 | No | No | Current |