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United States · US · US:0046-1101_7b9a0278-b55c-41c5-ba63-c46d05a60918
Premarin
Orange BookUNIISPLATC G03CA57
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
CountryUS (United States)
ATC codeG03CA57
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110046110181100 TABLET, FILM COATED in 1 BOTTLE (0046-1101-81)
Annotations
UNII (FDA Substance ID)
IU5QR144QX
ESTROGENS, CONJUGATED
RxCUI 4099
Orange Book
N004782
ABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "IU5QR144QX",
"rxcui": "4099",
"inchikey": null,
"display_name": "ESTROGENS, CONJUGATED",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"258e1602-a3cf-4ccc-ca80-73dbbfb812ff": {
"match": "brand_token",
"title": "PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
"spl_version": "36",
"published_date": "2026-02-23"
}
},
"productid": "0046-1101_7b9a0278-b55c-41c5-ba63-c46d05a60918",
"productndc": "0046-1101",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "004782",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1.25MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2.5MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.3MG",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.625MG",
"product_no": "004",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.9MG",
"product_no": "005",
"approval_date": "Jan 26, 1984"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.45MG",
"product_no": "006",
"approval_date": "Jul 16, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTROGENS, CONJUGATED",
"proprietary_name": "Premarin",
"active_ingred_unit": "mg/1",
"application_number": "NDA004782",
"marketing_category": "NDA",
"nonproprietary_name": "estrogens, conjugated",
"start_marketing_date": "20060101",
"active_numerator_strength": ".45"
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