🇺🇸
United States · US · US:69238-1251_16c8c503-117a-47cf-9770-b7c5185e20cf
Lopreeza
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238125185 CARTON in 1 CELLO PACK (69238-1251-8) / 1 DIALPACK in 1 CARTON (69238-1251-6) / 28 TABLET, FILM COATED in 1 DIALPACK
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": {
"966ac064-9eb7-4d15-b271-a7880ed1e79a": {
"match": "brand_token",
"title": "LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]",
"spl_version": "10",
"published_date": "2025-01-24"
}
},
"productid": "69238-1251_16c8c503-117a-47cf-9770-b7c5185e20cf",
"productndc": "69238-1251",
"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"strength": "0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "Lopreeza",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA020907",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "estradiol/norethindrone acetate",
"start_marketing_date": "20141001",
"active_numerator_strength": "1; .5"
}Related drugs
Other records sharing ATC code G03CA.
Access this data programmatically
Query Lopreeza and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.