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NDC 16714-0535-01 Posaconazole 100 mg/1 Details
Posaconazole 100 mg/1
Posaconazole is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by NorthStar RxLLC. The primary component is POSACONAZOLE.
MedlinePlus Drug Summary
Posaconazole is used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection. Posaconazole delayed-release tablets are used to treat invasive aspergillosis (a serious fungal infection that begins in the lungs and spreads through the bloodstream to other organs) in adults and teenagers 13 years of age and older. Posaconazole oral suspension is also used to treat yeast infections of the mouth and throat including yeast infections in adults and teenagers 13 years of age and older that could not be treated successfully with other medications. Posaconazole is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.
Related Packages: 16714-0535-01Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Posaconazole
Product Information
| NDC | 16714-0535 |
|---|---|
| Product ID | 16714-535_f00461e3-12cb-3905-e053-2a95a90a4e12 |
| Associated GPIs | |
| GCN Sequence Number | 071709 |
| GCN Sequence Number Description | posaconazole TABLET DR 100 MG ORAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 35649 |
| HICL Sequence Number | 033461 |
| HICL Sequence Number Description | POSACONAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Posaconazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Posaconazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | POSACONAZOLE |
| Labeler Name | NorthStar RxLLC |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214321 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16714-0535-01 (16714053501)
| NDC Package Code | 16714-535-01 |
|---|---|
| Billing NDC | 16714053501 |
| Package | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-535-01) |
| Marketing Start Date | 2023-04-02 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 6.58425 |
| Pricing Unit | EA |
| Effective Date | 2023-12-20 |
| NDC Description | POSACONAZOLE DR 100 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |