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NDC 72187-0102-03 ORSERDU 345 mg/1 Details
ORSERDU 345 mg/1
ORSERDU is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Stemline Therapeutics, Inc.. The primary component is ELACESTRANT.
MedlinePlus Drug Summary
Elacestrant is used to treat certain types of hormone receptor-positive breast cancer (breast cancer that depends on hormones such as estrogen to grow) in adults who have had disease progression following treatment with at least one other hormone therapies. Elacestrant is in a class of medications called estrogen receptor antagonists. It works by stopping growth of cancer cells, dependent on estrogen, by blocking the ability of estrogen to bind.
Related Packages: 72187-0102-03Last Updated: 05/19/2024
MedLinePlus Full Drug Details: Elacestrant
Product Information
NDC | 72187-0102 |
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Product ID | 72187-0102_8195fa6c-91ac-4fe6-af1b-33881aae7e4c |
Associated GPIs | |
GCN Sequence Number | 084359 |
GCN Sequence Number Description | elacestrant HCl TABLET 345 MG ORAL |
HIC3 | V1T |
HIC3 Description | SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERMS) |
GCN | 53629 |
HICL Sequence Number | 048658 |
HICL Sequence Number Description | ELACESTRANT HCL |
Brand/Generic | Brand |
Proprietary Name | ORSERDU |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Elacestrant |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 345 |
Active Ingredient Units | mg/1 |
Substance Name | ELACESTRANT |
Labeler Name | Stemline Therapeutics, Inc. |
Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA217639 |
Listing Certified Through | 2024-12-31 |
Package
NDC 72187-0102-03 (72187010203)
NDC Package Code | 72187-0102-3 |
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Billing NDC | 72187010203 |
Package | 30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3) |
Marketing Start Date | 2023-01-27 |
NDC Exclude Flag | N |
Pricing Information | N/A |