Climara

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5041945204
4 PATCH in 1 CARTON (50419-452-04) / 7 d in 1 PATCH (50419-452-01)

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

N020375

AB2AB2AB2AB2AB2AB2

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4TI98Z838E",
    "rxcui": "4083",
    "inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
    "display_name": "ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "1e9702c4-f2d7-4ea8-b6e8-7dca31671864": {
      "match": "brand_token",
      "title": "CLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "25",
      "published_date": "2026-03-30"
    }
  },
  "productid": "50419-452_c092f921-73f7-45be-b928-744cfdd24b49",
  "productndc": "50419-452",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "020375",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "0.05MG/24HR",
        "product_no": "001",
        "approval_date": "Dec 22, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "0.1MG/24HR",
        "product_no": "002",
        "approval_date": "Dec 22, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "0.075MG/24HR",
        "product_no": "003",
        "approval_date": "Mar 23, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "0.025MG/24HR",
        "product_no": "004",
        "approval_date": "Mar 5, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "0.0375MG/24HR",
        "product_no": "005",
        "approval_date": "May 27, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "0.06MG/24HR",
        "product_no": "006",
        "approval_date": "May 27, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Climara",
  "active_ingred_unit": "mg/d",
  "application_number": "NDA020375",
  "marketing_category": "NDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "19941222",
  "active_numerator_strength": ".1"
}

Related drugs

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