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NDC 00781-9055-12 Fulvestrant 50 mg/mL Details
Fulvestrant 50 mg/mL
Fulvestrant is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc. The primary component is FULVESTRANT.
MedlinePlus Drug Summary
Fulvestrant injection is used alone or in combination with another chemotherapy medication 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 certain other chemotherapy medications to treat a certain type of hormone receptor positive, advanced breast cancer or breast cancer that has spread to other parts of the body in adults whose cancer got worse during or after certain other treatments. 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: 00781-9055-12Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Fulvestrant Injection
Product Information
| NDC | 00781-9055 |
|---|---|
| Product ID | 0781-9055_7a03f714-b109-4256-80a6-78c82127d624 |
| Associated GPIs | |
| 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 |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | FULVESTRANT |
| Labeler Name | Sandoz Inc |
| Pharmaceutical Class | Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205935 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00781-9055-12 (00781905512)
| NDC Package Code | 0781-9055-12 |
|---|---|
| Billing NDC | 00781905512 |
| Package | 2 SYRINGE, GLASS in 1 CARTON (0781-9055-12) / 5 mL in 1 SYRINGE, GLASS (0781-9055-01) |
| Marketing Start Date | 2023-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |