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NDC 00378-0144-91 Tamoxifen Citrate 10 mg/1 Details
Tamoxifen Citrate 10 mg/1
Tamoxifen Citrate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is TAMOXIFEN CITRATE.
MedlinePlus Drug Summary
Tamoxifen is used to treat breast cancer that has spread to other parts of the body in men and women. It is used to treat early breast cancer in women who have already been treated with surgery, radiation, and/or chemotherapy. It is used to reduce the risk of developing a more serious type of breast cancer in women who have had ductal carcinoma in situ (DCIS; a type of breast cancer that does not spread outside of the milk duct where it forms) and who have been treated with surgery and radiation. It is used to reduce the risk of breast cancer in women who are at high risk for the disease due to their age, personal medical history, and family medical history. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow.
Related Packages: 00378-0144-91Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tamoxifen
Product Information
| NDC | 00378-0144 |
|---|---|
| Product ID | 0378-0144_a18ae721-cd2b-4fd9-af68-610b3b65c7e2 |
| Associated GPIs | 21402680100310 |
| GCN Sequence Number | 008832 |
| GCN Sequence Number Description | tamoxifen citrate TABLET 10 MG ORAL |
| HIC3 | V1T |
| HIC3 Description | SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERMS) |
| GCN | 38720 |
| HICL Sequence Number | 003926 |
| HICL Sequence Number Description | TAMOXIFEN CITRATE |
| Brand/Generic | Generic |
| Proprietary Name | Tamoxifen Citrate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tamoxifen Citrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | TAMOXIFEN CITRATE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074732 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-0144-91 (00378014491)
| NDC Package Code | 0378-0144-91 |
|---|---|
| Billing NDC | 00378014491 |
| Package | 60 TABLET in 1 BOTTLE (0378-0144-91) |
| Marketing Start Date | 2004-02-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.2011 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | TAMOXIFEN 10 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |