🇺🇸
United States · US · US:71335-0445_5f5f09d7-aaf1-4926-9ed5-7bc5f3fa20b6
Estradiol
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc117133504451100 TABLET in 1 BOTTLE (71335-0445-1)
- ndc11713350445230 TABLET in 1 BOTTLE (71335-0445-2)
- ndc11713350445390 TABLET in 1 BOTTLE (71335-0445-3)
- ndc11713350445460 TABLET in 1 BOTTLE (71335-0445-4)
- ndc117133504455180 TABLET in 1 BOTTLE (71335-0445-5)
- ndc117133504456120 TABLET in 1 BOTTLE (71335-0445-6)
- ndc11713350445728 TABLET in 1 BOTTLE (71335-0445-7)
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A040197
ABABAB
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": "71335-0445_5f5f09d7-aaf1-4926-9ed5-7bc5f3fa20b6",
"productndc": "71335-0445",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040197",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Oct 22, 1997"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Oct 22, 1997"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Oct 22, 1997"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "Estradiol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040197",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "19971028",
"active_numerator_strength": "1"
}Related drugs
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- 🇺🇸ClimaraBayer HealthCare Pharmaceuticals Inc.
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