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United States · US · US:0046-1105_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

  • ndc11
    0046110511
    1 BLISTER PACK in 1 CARTON (0046-1105-11) / 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": "0046-1105_cce04608-5f9f-434f-b4ab-d5c19847095a",
  "productndc": "0046-1105",
  "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": ".3; 1.5"
}

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