Posaconazole
- Product NDC
- 72319-023
- 11-digit product format
- 723190023
- Labeler code
- 72319
- Product ID
- 72319-023_3249c585-7620-444f-e063-6294a90ae5ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Posaconazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- i3 Pharmaceuticals, LLC
- Application
- ANDA216488
- Marketing category
- ANDA
- Marketing start
- 2023-09-15
- Substance
- POSACONAZOLE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Posaconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POSACONAZOLE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6TK1G07BHZ |
| Rxcui | 1482908 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72319-023-02 | Posaconazole | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72319-023 | POSACONAZOLE TABLET, DELAYED RELEASE [I3 PHARMACEUTICALS, LLC] | 4 | Current NDC, 1 package rows | 20250410_d5300d14-219d-4e1e-bfac-b413c40d6e3a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72319-023-02 | 72319002302 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72319-023-02) | 2023-09-15 | No | No | Historical |