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United States · US · US:79929-012_1a990fcf-1731-8ca1-e063-6294a90ac9c8
ESTRADIOL AND NORETHINDRONE ACETATE
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNaari Pte. Limited
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11799290120784 BLISTER PACK in 1 POUCH (79929-012-07) / 28 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A210233
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": {
"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": "79929-012_1a990fcf-1731-8ca1-e063-6294a90ac9c8",
"productndc": "79929-012",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210233",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG;0.5MG",
"product_no": "001",
"approval_date": "Feb 28, 2018"
}
],
"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": "ANDA210233",
"marketing_category": "ANDA",
"nonproprietary_name": "estradiol and norethindrone acetate",
"start_marketing_date": "20240611",
"active_numerator_strength": "1; .5"
}Related drugs
Other records sharing ATC code G03CA.
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