posaconazole
- Product NDC
- 0054-0449
- 11-digit product format
- 000540449
- Labeler code
- 0054
- Product ID
- 0054-0449_216b2666-3f04-4cb4-acea-e73ed7037a10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- posaconazole
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA208773
- Marketing category
- ANDA
- Marketing start
- 2023-03-29
- Substance
- POSACONAZOLE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6TK1G07BHZ |
| Rxcui | 665019 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0449-49 | posaconazole | 105 mL in 1 BOTTLE, GLASS | SUSPENSION | 105 | | 10 |
| 0054-0449-49 | posaconazole | 1 in 1 CARTON | SUSPENSION | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0449 | POSACONAZOLE SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] | 6 | Current NDC, 2 package rows | 20241211_282ddea7-47d8-44e4-8806-169d7cafa951.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0449-49 | 00054044949 | 1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASS | 2023-03-29 | No | No | Current |