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NDC 70121-1463-02 Fulvestrant 250 mg/5mL Details
Fulvestrant 250 mg/5mL
Fulvestrant is a INTRAMUSCULAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is FULVESTRANT.
MedlinePlus Drug Summary
Fulvestrant injection is used alone or in combination with ribociclib (Kisqali®) to treat a certain type of hormone receptor positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer has spread to other parts of the body in women who have experienced menopause (change of life; end of monthly menstrual periods) and have not previously been treated with an anti-estrogen medication such as tamoxifen (Nolvadex). Fulvestrant injection is also used alone or in combination with ribociclib (Kisqali®) to treat hormone receptor positive, advanced breast cancer or breast cancer that has spread to other parts of the body in women who have experienced menopause and whose breast cancer has worsened after they were treated with an anti-estrogen medication such as tamoxifen. Fulvestrant injection is also used in combination with palbociclib (Ibrance®) or abemaciclib (Verzenio®) to treat hormone receptor positive, advanced breast cancer in women whose breast cancer has spread to other parts of the body and has worsened after they were treated with anti-estrogen medication such as tamoxifen. Fulvestrant is in a class of medications called estrogen receptor antagonists. It works by blocking the action of estrogen on cancer cells. This can slow or stop the growth of some breast tumors that need estrogen to grow.
Related Packages: 70121-1463-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fulvestrant Injection
Product Information
NDC | 70121-1463 |
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Product ID | 70121-1463_57de7dfe-c139-4710-838f-416643a906d8 |
Associated GPIs | 21403530002024 |
GCN Sequence Number | 050307 |
GCN Sequence Number Description | fulvestrant SYRINGE 250 MG/5ML INTRAMUSC |
HIC3 | V1T |
HIC3 Description | SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERMS) |
GCN | 17307 |
HICL Sequence Number | 023523 |
HICL Sequence Number Description | FULVESTRANT |
Brand/Generic | Generic |
Proprietary Name | Fulvestrant |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Fulvestrant |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAMUSCULAR |
Active Ingredient Strength | 250 |
Active Ingredient Units | mg/5mL |
Substance Name | FULVESTRANT |
Labeler Name | Amneal Pharmaceuticals LLC |
Pharmaceutical Class | Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA210044 |
Listing Certified Through | 2024-12-31 |
Package
NDC 70121-1463-02 (70121146302)
NDC Package Code | 70121-1463-2 |
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Billing NDC | 70121146302 |
Package | 2 SYRINGE, GLASS in 1 CARTON (70121-1463-2) / 5 mL in 1 SYRINGE, GLASS |
Marketing Start Date | 2019-03-04 |
NDC Exclude Flag | N |
Pricing Information | N/A |