Tamoxifen Citrate Tablet, Film Coated
NDC 68071-3990

The NDC code 68071-3990 is assigned by the FDA to the product Tamoxifen Citrate. This pharmaceutical product is labeled by Nucare Pharmaceuticals, Inc. and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68071-3990-3. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

Metastatic Breast Cancer:Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablets therapy.Adjuvant Treatment of Breast Cancer:Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.Tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate tablets therapy are likely to be beneficial.Tamoxifen citrate tablets reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate tablets therapy for breast cancer.Ductal Carcinoma in Situ (DCIS):In women with DCIS, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see  BOXED WARNING  at the beginning of the label). The decision regarding therapy with tamoxifen citrate tablets for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate tablets therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate tablets therapy for patients with breast cancer.Reduction in Breast Cancer Incidence in High Risk Women:Tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see  BOXED WARNING at the beginning of the label). Tamoxifen citrate tablets are indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model.Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are:Age 35 or older and any of the following combination of factors:One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; orAt least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; orLCISAge 40 or older and any of the following combination of factors:One first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; orAt least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; orOne first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia.Age 45 or older and any of the following combination of factors:At least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; orOne first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more.Age 50 or older and any of the following combination of factors:At least 2 first degree relatives with a history of breast cancer; orHistory of one breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; orHistory of at least two breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more.Age 55 or older and any of the following combination of factors:One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; orHistory of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older.Age 60 or older and:5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model.For women whose risk factors are not described in the above examples, the Gail Model is necessary to estimate absolute breast cancer risk. Health Care Professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-866-850-2876.There are insufficient data available regarding the effect of tamoxifen citrate tablets on breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of tamoxifen citrate in these patients.After an assessment of the risk of developing breast cancer, the decision regarding therapy with tamoxifen citrate tablets for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate tablets therapy. In the NSABP P-1 trial, tamoxifen citrate tablets treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk (See Table 3 in   CLINICAL PHARMACOLOGY).

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

• TAMOXIFEN CITRATE 10 mg/1 - One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

• RxCUI: 198240 - tamoxifen citrate 10 MG Oral Tablet
• RxCUI: 198240 - tamoxifen 10 MG Oral Tablet
• RxCUI: 198240 - tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral Tablet

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

• Estrogen Agonist/Antagonist - [EPC] (Established Pharmacologic Class)
• Selective Estrogen Receptor Modulators - [MoA] (Mechanism of Action)