Premarin

Orange BookUNIISPLATC G03CA57

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
0046087204
1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-04) / 4 g in 1 TUBE, WITH APPLICATOR
ndc11
0046087221
1 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-21) / 30 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)

IU5QR144QX

ESTROGENS, CONJUGATED

RxCUI 4099

Orange Book

N020216

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": "VAGINAL",
  "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": "0046-0872_94b7195e-3ce2-4e04-a814-9b63add4896e",
  "productndc": "0046-0872",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "020216",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.625MG/GM",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTROGENS, CONJUGATED",
  "proprietary_name": "Premarin",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA020216",
  "marketing_category": "NDA",
  "nonproprietary_name": "conjugated estrogens",
  "start_marketing_date": "19781101",
  "active_numerator_strength": ".625"
}

Related drugs

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