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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6TK1G07BHZ | POSACONAZOLE | 171228-49-2 | POSACONAZOLE |
Packages
| 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 | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| POSACONAZOLE | ENDO USA, Inc. | Merck Sharp & Dohme LLC | 2026-02-18 | HUMAN PRESCRIPTION DRUG LABEL | 15 |