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United States · US · US:0046-1106_cce04608-5f9f-434f-b4ab-d5c19847095a
Prempro
Orange BookUNIIATC G03EA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
CountryUS (United States)
ATC codeG03EA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100461106111 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
IU5QR144QX
ESTROGENS, CONJUGATED
RxCUI 4099
Orange Book
N020527
Raw payload (JSON)
{
"unii": {
"unii": "IU5QR144QX",
"rxcui": "4099",
"inchikey": null,
"display_name": "ESTROGENS, CONJUGATED",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "0046-1106_cce04608-5f9f-434f-b4ab-d5c19847095a",
"productndc": "0046-1106",
"dosage_form": "TABLET, SUGAR COATED",
"orange_book": {
"appl_no": "020527",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.625MG;2.5MG",
"product_no": "001",
"approval_date": "Nov 17, 1995"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.625MG,0.625MG;N/A,5MG",
"product_no": "002",
"approval_date": "Nov 17, 1995"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.625MG;5MG",
"product_no": "003",
"approval_date": "Jan 9, 1998"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.45MG;1.5MG",
"product_no": "004",
"approval_date": "Mar 12, 2003"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.3MG;1.5MG",
"product_no": "005",
"approval_date": "Jun 4, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
"proprietary_name": "Prempro",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA020527",
"marketing_category": "NDA",
"nonproprietary_name": "conjugated estrogens and medroxyprogesterone acetate",
"start_marketing_date": "20090921",
"active_numerator_strength": ".45; 1.5"
}Related drugs
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