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United States · US · US:50742-657_b156b1fa-c3f8-42fd-a8e3-e1f9c58e0175
Estradiol and Norethindrone Acetate
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1150742657281 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACK
- ndc1150742657686 BLISTER PACK in 1 CARTON (50742-657-68) / 28 TABLET in 1 BLISTER PACK
- ndc1150742657843 BLISTER PACK in 1 CARTON (50742-657-84) / 28 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A210612
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": "50742-657_b156b1fa-c3f8-42fd-a8e3-e1f9c58e0175",
"productndc": "50742-657",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210612",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG;0.1MG",
"product_no": "001",
"approval_date": "Apr 3, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG;0.5MG",
"product_no": "002",
"approval_date": "Apr 3, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
"proprietary_name": "Estradiol and Norethindrone Acetate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA210612",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol and Norethindrone Acetate",
"start_marketing_date": "20190403",
"active_numerator_strength": "1; .5"
}Related drugs
Other records sharing ATC code G03CA.
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