POSACONAZOLE
- Product NDC
- 70377-038
- 11-digit product format
- 703770038
- Labeler code
- 70377
- Product ID
- 70377-038_b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Posaconazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Biocon Phama Inc.
- Application
- ANDA214476
- Marketing category
- ANDA
- Marketing start
- 2022-03-08
- 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 |
|---|
| 70377-038-11 | POSACONAZOLE | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-038 | POSACONAZOLE TABLET, DELAYED RELEASE [BIOCON PHAMA INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20220429_e0e8023a-3c82-e455-a57b-ccc0206ad156.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 |
|---|
| 70377-038-11 | 70377003811 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11) | 2022-03-08 | 0000-00-00 | No | No | Current |