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NDC 00591-4365-60 Abiraterone acetate 500 mg/1 Details
Abiraterone acetate 500 mg/1
Abiraterone acetate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is ABIRATERONE ACETATE.
MedlinePlus Drug Summary
Abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has spread to other parts of the body. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.
Related Packages: 00591-4365-60Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Abiraterone
Product Information
| NDC | 00591-4365 |
|---|---|
| Product ID | 0591-4365_4333e903-cbd7-4f97-a190-8b2433833f28 |
| Associated GPIs | |
| GCN Sequence Number | 077249 |
| GCN Sequence Number Description | abiraterone acetate TABLET 500 MG ORAL |
| HIC3 | V1J |
| HIC3 Description | ANTINEOPLASTIC - ANTIANDROGENIC AGENTS |
| GCN | 43205 |
| HICL Sequence Number | 037571 |
| HICL Sequence Number Description | ABIRATERONE ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Abiraterone acetate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Abiraterone acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | ABIRATERONE ACETATE |
| Labeler Name | Actavis Pharma, Inc. |
| Pharmaceutical Class | Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210726 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00591-4365-60 (00591436560)
| NDC Package Code | 0591-4365-60 |
|---|---|
| Billing NDC | 00591436560 |
| Package | 60 TABLET, FILM COATED in 1 BOTTLE (0591-4365-60) |
| Marketing Start Date | 2023-07-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |