POSACONAZOLE
- Product NDC
- 0406-7711
- 11-digit product format
- 004067711
- Labeler code
- 0406
- Product ID
- 0406-7711_d1fe133e-822b-49de-9684-4501a5b0bbbf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- posaconazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA212226
- Marketing category
- ANDA
- Marketing start
- 2022-05-10
- 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 |
|---|
| 0406-7711-60 | POSACONAZOLE | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-7711 | POSACONAZOLE TABLET, DELAYED RELEASE [SPECGX LLC] | 12 | Current NDC, Legacy NDC, 1 package rows | 20250117_8412398b-c696-4f12-ba3a-da74dc8dadaf.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 |
|---|
| 0406-7711-60 | 00406771160 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0406-7711-60) | 2022-05-10 | 0000-00-00 | No | No | Current |