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NDC 65162-0807-50 Progesterone 100 mg/1 Details
Progesterone 100 mg/1
Progesterone is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is PROGESTERONE.
MedlinePlus Drug Summary
Progesterone is used as a part of hormone replacement therapy in women who have passed menopause (the change of life) and have not had a hysterectomy (surgery to remove the uterus). Hormone replacement therapy usually includes estrogen, which is used to treat symptoms of menopause and reduce the risk of developing certain diseases. However, estrogen can also cause abnormal thickening of the lining of the uterus and increase the risk of developing uterine cancer. Progesterone helps to prevent this thickening and decreases the risk of developing uterine cancer. Progesterone is also used to bring on menstruation (period) in women of childbearing age who have had normal periods and then stopped menstruating. Progesterone is in a class of medications called progestins (female hormones). It works as part of hormone replacement therapy by decreasing the amount of estrogen in the uterus. It works to bring on menstruation by replacing the natural progesterone that some women are missing.
Related Packages: 65162-0807-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Progesterone
Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy. Progestin is a female hormone. It works by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus. Progestin-only (norethindrone) oral contraceptives are a very effective method of birth control, but they do not prevent the spread of AIDS and other sexually transmitted diseases.
Related Packages: 65162-0807-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Progestin-Only (norethindrone) Oral Contraceptives
Product Information
NDC | 65162-0807 |
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Product ID | 65162-807_bffb6ed6-c9ab-46e4-8ac4-3ca463796a5b |
Associated GPIs | 26000040000120 |
GCN Sequence Number | 043801 |
GCN Sequence Number Description | progesterone, micronized CAPSULE 100 MG ORAL |
HIC3 | G2A |
HIC3 Description | PROGESTATIONAL AGENTS |
GCN | 50776 |
HICL Sequence Number | 020653 |
HICL Sequence Number Description | PROGESTERONE, MICRONIZED |
Brand/Generic | Generic |
Proprietary Name | Progesterone |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Progesterone |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | CAPSULE |
Route | ORAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/1 |
Substance Name | PROGESTERONE |
Labeler Name | Amneal Pharmaceuticals LLC |
Pharmaceutical Class | Progesterone [CS], Progesterone [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA207724 |
Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0807-50 (65162080750)
NDC Package Code | 65162-807-50 |
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Billing NDC | 65162080750 |
Package | 500 CAPSULE in 1 BOTTLE (65162-807-50) |
Marketing Start Date | 2017-09-11 |
NDC Exclude Flag | N |
Pricing Information | N/A |