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NDC 43598-0505-01 Raloxifene hydrochloride 60 mg/1 Details
Raloxifene hydrochloride 60 mg/1
Raloxifene hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr.Reddy. The primary component is RALOXIFENE HYDROCHLORIDE.
MedlinePlus Drug Summary
Raloxifene is used to prevent and treat osteoporosis (condition in which the bones become thin and weak and break easily) in postmenopausal (women who have experienced a change of life; end of menstrual periods) women. Raloxifene is also used to decrease the risk of developing invasive breast cancer (breast cancer that has spread outside of the milk ducts or lobules into the surrounding breast tissue) in postmenopausal women who are at high risk of developing this type of cancer or who have osteoporosis. Raloxifene cannot be used to treat invasive breast cancer or to prevent invasive breast cancer from coming back in women who have already had the condition. Raloxifene also cannot be used to decrease the risk of developing noninvasive breast cancer. Raloxifene should not be used in women who have not yet experienced menopause. Raloxifene is in a class of medications called selective estrogen receptor modulators (SERMs). Raloxifene prevents and treats osteoporosis by mimicking the effects of estrogen (a female hormone produced by the body) to increase the density (thickness) of bone. Raloxifene decreases the risk of developing invasive breast cancer by blocking the effects of estrogen on breast tissue. This may stop the development of tumors that need estrogen to grow.
Related Packages: 43598-0505-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Raloxifene
Product Information
NDC | 43598-0505 |
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Product ID | 43598-505_f08636b3-11f2-23f1-e053-2a95a90a12e5 |
Associated GPIs | 30053060100320 |
GCN Sequence Number | 037022 |
GCN Sequence Number Description | raloxifene HCl TABLET 60 MG ORAL |
HIC3 | P4L |
HIC3 Description | BONE RESORPTION INHIBITORS |
GCN | 59011 |
HICL Sequence Number | 016917 |
HICL Sequence Number Description | RALOXIFENE HCL |
Brand/Generic | Generic |
Proprietary Name | Raloxifene hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Raloxifene hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 60 |
Active Ingredient Units | mg/1 |
Substance Name | RALOXIFENE HYDROCHLORIDE |
Labeler Name | Dr.Reddy |
Pharmaceutical Class | Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA206384 |
Listing Certified Through | 2024-12-31 |
Package
NDC 43598-0505-01 (43598050501)
NDC Package Code | 43598-505-01 |
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Billing NDC | 43598050501 |
Package | 100 TABLET, FILM COATED in 1 BOTTLE (43598-505-01) |
Marketing Start Date | 2016-10-12 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.29095 |
Pricing Unit | EA |
Effective Date | 2024-02-21 |
NDC Description | RALOXIFENE HCL 60 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |