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United States · US · US:70700-330_35d8f763-8f98-f5ea-fae8-1367b638e82c
ABIGALE
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXiromed LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170700330853 POUCH in 1 CARTON (70700-330-85) / 1 BLISTER PACK in 1 POUCH (70700-330-84) / 28 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A207261
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": {
"df013d36-de10-0607-7e12-95ed43bf7ee9": {
"match": "brand_token",
"title": "ABIGALE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET ABIGALE LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [XIROMED LLC]",
"spl_version": "1",
"published_date": "2025-03-06"
}
},
"productid": "70700-330_35d8f763-8f98-f5ea-fae8-1367b638e82c",
"productndc": "70700-330",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207261",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG;0.1MG",
"product_no": "001",
"approval_date": "Feb 10, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG;0.5MG",
"product_no": "002",
"approval_date": "Feb 10, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
"proprietary_name": "ABIGALE",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA207261",
"marketing_category": "ANDA",
"nonproprietary_name": "estradiol and norethindrone acetate",
"start_marketing_date": "20250129",
"active_numerator_strength": "1; .5"
}Related drugs
Other records sharing ATC code G03CA.
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