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NDC 50261-0211-05 Bijuva 1; 100 mg/1; mg/1 Details
Bijuva 1; 100 mg/1; mg/1
Bijuva is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mayne Pharma LLC. The primary component is ESTRADIOL; PROGESTERONE.
MedlinePlus Drug Summary
Combinations of estrogen and progestin are used to treat certain symptoms of menopause. Estrogen and progestin are two female sex hormones. Hormone replacement therapy works by replacing estrogen hormone that is no longer being made by the body. Estrogen reduces feelings of warmth in the upper body and periods of sweating and heat (hot flashes), vaginal symptoms (itching, burning, and dryness) and difficulty with urination, but it does not relieve other symptoms of menopause such as nervousness or depression. Estrogen also prevents thinning of the bones (osteoporosis) in menopausal women. Progestin is added to estrogen in hormone replacement therapy to reduce the risk of uterine cancer in women who still have their uterus.
Related Packages: 50261-0211-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Estrogen and Progestin (Hormone Replacement Therapy)
Product Information
| NDC | 50261-0211 |
|---|---|
| Product ID | 50261-211_306280d6-5026-479c-bf5b-287fbcd855ec |
| Associated GPIs | 24993002140120 |
| GCN Sequence Number | 079208 |
| GCN Sequence Number Description | estradiol/progesterone CAPSULE 1 MG-100MG ORAL |
| HIC3 | G1F |
| HIC3 Description | ESTROGEN AND PROGESTIN COMBINATIONS |
| GCN | 45661 |
| HICL Sequence Number | 001417 |
| HICL Sequence Number Description | ESTRADIOL/PROGESTERONE |
| Brand/Generic | Brand |
| Proprietary Name | Bijuva |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | estradiol and progesterone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 1; 100 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ESTRADIOL; PROGESTERONE |
| Labeler Name | Mayne Pharma LLC |
| Pharmaceutical Class | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210132 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50261-0211-05 (50261021105)
| NDC Package Code | 50261-211-05 |
|---|---|
| Billing NDC | 50261021105 |
| Package | 1 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2019-04-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |