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NDC 00517-0420-01 ESTRADIOL VALERATE 20 mg/mL Details
ESTRADIOL VALERATE 20 mg/mL
ESTRADIOL VALERATE is a INTRAMUSCULAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is ESTRADIOL VALERATE.
MedlinePlus Drug Summary
The estradiol cypionate and estradiol valerate forms of estrogen injection are used to treat hot flushes (hot flashes; sudden strong feelings of heat and sweating) and/or vaginal dryness, itching, and burning in women who are experiencing menopause (change of life; the end of monthly menstrual periods). However, women who need a medication only to treat vaginal dryness, itching, or burning should consider a different treatment. These forms of estrogen injection are also sometimes used to treat the symptoms of low estrogen in young women who do not produce enough estrogen naturally. The estradiol valerate form of estrogen injection is also sometimes used to relieve the symptoms of certain types of prostate (a male reproductive organ) cancer. The conjugated estrogens form of estrogen injection is used to treat abnormal vaginal bleeding that a doctor has decided is caused only by a problem with the amounts of certain hormones in the body. Estrogen injection is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
Related Packages: 00517-0420-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Estrogen Injection
Product Information
NDC | 00517-0420 |
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Product ID | 0517-0420_34294770-179c-4b76-b20f-9e842e156851 |
Associated GPIs | 24000035201710 |
GCN Sequence Number | 003199 |
GCN Sequence Number Description | estradiol valerate VIAL 20 MG/ML INTRAMUSC |
HIC3 | G1A |
HIC3 Description | ESTROGENIC AGENTS |
GCN | 10690 |
HICL Sequence Number | 001420 |
HICL Sequence Number Description | ESTRADIOL VALERATE |
Brand/Generic | Generic |
Proprietary Name | ESTRADIOL VALERATE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ESTRADIOL VALERATE |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAMUSCULAR |
Active Ingredient Strength | 20 |
Active Ingredient Units | mg/mL |
Substance Name | ESTRADIOL VALERATE |
Labeler Name | American Regent, Inc. |
Pharmaceutical Class | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA090920 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00517-0420-01 (00517042001)
NDC Package Code | 0517-0420-01 |
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Billing NDC | 00517042001 |
Package | 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE |
Marketing Start Date | 2020-03-01 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 21.5898 |
Pricing Unit | ML |
Effective Date | 2024-02-21 |
NDC Description | ESTRADIOL VALERATE 100 MG/5 ML |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1, 5 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |