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NDC 72974-0120-01 Orgovyx 120 mg/1 Details
Orgovyx 120 mg/1
Orgovyx is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sumitomo Pharma America, Inc. The primary component is RELUGOLIX.
MedlinePlus Drug Summary
Relugolix is used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]) in adults. Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.
Related Packages: 72974-0120-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Relugolix
Product Information
| NDC | 72974-0120 |
|---|---|
| Product ID | 72974-120_2ec7524a-0548-48eb-b59b-09fbe985f8ea |
| Associated GPIs | 21405570000320 |
| GCN Sequence Number | 081783 |
| GCN Sequence Number Description | relugolix TABLET 120 MG ORAL |
| HIC3 | V1V |
| HIC3 Description | ANTINEOPLASTIC LHRH(GNRH) ANTAGONIST,PITUIT.SUPPRS |
| GCN | 49005 |
| HICL Sequence Number | 047035 |
| HICL Sequence Number Description | RELUGOLIX |
| Brand/Generic | Brand |
| Proprietary Name | Orgovyx |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | relugolix |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/1 |
| Substance Name | RELUGOLIX |
| Labeler Name | Sumitomo Pharma America, Inc |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Anta |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA214621 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72974-0120-01 (72974012001)
| NDC Package Code | 72974-120-01 |
|---|---|
| Billing NDC | 72974012001 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01) |
| Marketing Start Date | 2020-12-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |