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United States · US · US:51991-623_d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689
Estradiol / Norethindrone Acetate
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBreckenridge Pharmaceutical, Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151991623281 BLISTER PACK in 1 CARTON (51991-623-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A078324
ABAB
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": {
"50c786d6-91bd-4eea-9455-ff2abc08372f": {
"match": "brand_token",
"title": "ESTRADIOL AND NORETHINDRONE ACETATE TABLET [INGENUS PHARMACEUTICALS, LLC]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "51991-623_d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689",
"productndc": "51991-623",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078324",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG;0.5MG",
"product_no": "001",
"approval_date": "Apr 17, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG;0.1MG",
"product_no": "002",
"approval_date": "Jun 9, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
"proprietary_name": "Estradiol / Norethindrone Acetate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA078324",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol and Norethindrone Acetate",
"start_marketing_date": "20110609",
"active_numerator_strength": ".5; .1"
}Related drugs
Other records sharing ATC code G03CA.
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