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United States · US · US:0046-1104_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 · 2

  • ndc11
    0046110481
    100 TABLET, FILM COATED in 1 BOTTLE (0046-1104-81)
  • ndc11
    0046110491
    1 BOTTLE in 1 CARTON (0046-1104-91) / 1000 TABLET, FILM COATED in 1 BOTTLE

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": "0046-1104_7b9a0278-b55c-41c5-ba63-c46d05a60918",
  "productndc": "0046-1104",
  "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": "20040901",
  "active_numerator_strength": "1.25"
}

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