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NDC 16714-0995-01 deferasirox 360 mg/1 Details
deferasirox 360 mg/1
deferasirox is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Northstar Rx LLC.. The primary component is DEFERASIROX.
MedlinePlus Drug Summary
Deferasirox is used to treat adults and children 2 years of age and older who have too much iron in their body because they received many blood transfusions. It is also used to treat adults and children 10 years of age and older who have too much iron in their body because of a genetic blood disorder called non–transfusion-dependent thalassemia (NTDT). Deferasirox is in a class of medications called iron chelators. It works by attaching to iron in the body so that it can be excreted (removed from the body) in feces.
Related Packages: 16714-0995-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Deferasirox
Product Information
| NDC | 16714-0995 |
|---|---|
| Product ID | 16714-995_985bacb0-2273-4e1f-b70b-0eaca6da536f |
| Associated GPIs | 93100025000340 |
| GCN Sequence Number | 073797 |
| GCN Sequence Number Description | deferasirox TABLET 360 MG ORAL |
| HIC3 | C8A |
| HIC3 Description | METALLIC POISON,AGENTS TO TREAT |
| GCN | 38246 |
| HICL Sequence Number | 033337 |
| HICL Sequence Number Description | DEFERASIROX |
| Brand/Generic | Generic |
| Proprietary Name | deferasirox |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | deferasirox |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 360 |
| Active Ingredient Units | mg/1 |
| Substance Name | DEFERASIROX |
| Labeler Name | Northstar Rx LLC. |
| Pharmaceutical Class | Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211383 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 16714-0995-01 (16714099501)
| NDC Package Code | 16714-995-01 |
|---|---|
| Billing NDC | 16714099501 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (16714-995-01) |
| Marketing Start Date | 2020-03-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |