POSACONAZOLE
- Product NDC
- 0254-2045
- 11-digit product format
- 002542045
- Labeler code
- 0254
- Product ID
- 0254-2045_15fdf050-71cb-476f-a7ce-38c40262f381
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- posaconazole
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- ENDO USA, Inc.
- Application
- NDA205053
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-08-30
- Substance
- POSACONAZOLE
- Active strength
- 100 mg/1
- 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 | 100 mg/1 |
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 |
|---|
| 0254-2045-02 | POSACONAZOLE | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0254-2045 | POSACONAZOLE TABLET, COATED POSACONAZOLE SUSPENSION [ENDO USA, INC.] | 13 | Current NDC, Legacy NDC, 1 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 0254-2045-02 | 00254204502 | 60 TABLET, COATED in 1 BOTTLE (0254-2045-02) | 2019-08-30 | 0000-00-00 | No | No | Current |