POSACONAZOLE
- Product NDC
- 62135-429
- 11-digit product format
- 621350429
- Labeler code
- 62135
- Product ID
- 62135-429_f043ffa5-9564-4a98-e053-2995a90af810
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Posaconazole Delayed-Release
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA212411
- Marketing category
- ANDA
- Marketing start
- 2019-08-28
- 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 |
|---|
| 62135-429-60 | POSACONAZOLE | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-429 | POSACONAZOLE (POSACONAZOLE DELAYED-RELEASE) TABLET [CHARTWELL RX, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20221221_f2baa339-75ff-4c03-8334-a88648f701f7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62135-429-60 | 62135042960 | 60 TABLET in 1 BOTTLE (62135-429-60) | 60 tablet | 2022-12-12 | 0000-00-00 | No | No | Current |