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United States · US · US:68968-0514_a8dddb67-4c56-4d1d-a4ce-83dc426d33f6
CombiPatch (estradiol/norethindrone acetate transdermal system)
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNoven Therapeutics, LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168968051488 POUCH in 1 CARTON (68968-0514-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
N020870
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": {
"83198ef1-11c4-11e4-9191-0800200c9a66": {
"match": "brand_token",
"title": "COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]",
"spl_version": "14",
"published_date": "2024-02-27"
}
},
"productid": "68968-0514_a8dddb67-4c56-4d1d-a4ce-83dc426d33f6",
"productndc": "68968-0514",
"dosage_form": "PATCH, EXTENDED RELEASE",
"orange_book": {
"appl_no": "020870",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.05MG/24HR;0.14MG/24HR",
"product_no": "001",
"approval_date": "Aug 7, 1998"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.05MG/24HR;0.25MG/24HR",
"product_no": "002",
"approval_date": "Aug 7, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
"proprietary_name": "CombiPatch (estradiol/norethindrone acetate transdermal system)",
"active_ingred_unit": "mg/d; mg/d",
"application_number": "NDA020870",
"marketing_category": "NDA",
"nonproprietary_name": "estradiol/norethindrone acetate transdermal system",
"start_marketing_date": "19980807",
"active_numerator_strength": ".05; .14"
}Related drugs
Other records sharing ATC code G03CA.
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