posaconazole
- Product NDC
- 68083-577
- 11-digit product format
- 680830577
- Labeler code
- 68083
- Product ID
- 68083-577_dea5abae-8195-49f7-89bb-2e624208abf0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- posaconazole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA217553
- Marketing category
- ANDA
- Marketing start
- 2023-12-26
- Substance
- POSACONAZOLE
- Active strength
- 18 mg/mL
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POSACONAZOLE | 18 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6TK1G07BHZ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-577-01 | posaconazole | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 68083-577-01 | posaconazole | 16.7 mL in 1 VIAL | INJECTION, SOLUTION | 16.7 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-577 | POSACONAZOLE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 8 | Current NDC, 2 package rows | 20241127_52d9d29e-4a37-4926-aa57-8477f5447b34.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-577-01 | 68083057701 | 1 VIAL in 1 CARTON (68083-577-01) / 16.7 mL in 1 VIAL | 1 vial | 2023-12-26 | No | No | Historical |