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United States · US · US:50419-491_9f4e7765-d4e7-4f36-9530-8b4444587214
Climara Pro
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150419491044 PATCH in 1 CARTON (50419-491-04) / 7 d in 1 PATCH
- ndc1150419491731 PATCH in 1 CARTON (50419-491-73) / 7 d in 1 PATCH
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
N021258
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": "50419-491_9f4e7765-d4e7-4f36-9530-8b4444587214",
"productndc": "50419-491",
"dosage_form": "PATCH",
"orange_book": {
"appl_no": "021258",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.045MG/24HR;0.015MG/24HR",
"product_no": "001",
"approval_date": "Nov 21, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL; LEVONORGESTREL",
"proprietary_name": "Climara Pro",
"active_ingred_unit": "mg/d; mg/d",
"application_number": "NDA021258",
"marketing_category": "NDA",
"nonproprietary_name": "Estradiol and Levonorgestrel",
"start_marketing_date": "20031121",
"active_numerator_strength": ".045; .015"
}Related drugs
Other records sharing ATC code G03CA.
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