🇺🇸
United States · US · US:50261-251_fca91f4b-94dd-41c9-90c3-c50c4b2dcd76
Bijuva
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150261251051 BLISTER PACK in 1 CARTON (50261-251-05) / 5 CAPSULE in 1 BLISTER PACK
- ndc1150261251301 BLISTER PACK in 1 CARTON (50261-251-30) / 30 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
N210132
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4TI98Z838E",
"rxcui": "4083",
"inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
"display_name": "ESTRADIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"59eadb88-c9f3-4871-b176-7ddd98faf9bc": {
"match": "brand_token",
"title": "BIJUVA (ESTRADIOL AND PROGESTERONE) CAPSULE [MAYNE PHARMA]",
"spl_version": "6",
"published_date": "2026-04-27"
}
},
"productid": "50261-251_fca91f4b-94dd-41c9-90c3-c50c4b2dcd76",
"productndc": "50261-251",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210132",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1MG;100MG",
"product_no": "001",
"approval_date": "Oct 28, 2018"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.5MG;100MG",
"product_no": "002",
"approval_date": "Dec 28, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL; PROGESTERONE",
"proprietary_name": "Bijuva",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA210132",
"marketing_category": "NDA",
"nonproprietary_name": "estradiol and progesterone",
"start_marketing_date": "20230331",
"active_numerator_strength": ".5; 100"
}Related drugs
Other records sharing ATC code G03CA.
Access this data programmatically
Query Bijuva and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.