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United States · US · US:60846-231_ec312506-ea70-4aa1-8c07-0347fe956a57
Activella
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160846231011 BLISTER PACK in 1 CARTON (60846-231-01) / 28 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
N020907
AB
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": {
"d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0": {
"match": "brand_token",
"title": "ACTIVELLA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "18",
"published_date": "2024-06-03"
}
},
"productid": "60846-231_ec312506-ea70-4aa1-8c07-0347fe956a57",
"productndc": "60846-231",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020907",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1MG;0.5MG",
"product_no": "001",
"approval_date": "Nov 18, 1998"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Dec 28, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
"proprietary_name": "Activella",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA020907",
"marketing_category": "NDA",
"nonproprietary_name": "Estradiol/norethindrone acetate",
"start_marketing_date": "20190501",
"active_numerator_strength": ".5; .1"
}Related drugs
Other records sharing ATC code G03CA.
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