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United States · US · US:65162-358_4370e72b-f961-453e-ab06-5d933a6f5b50
ZAFEMY
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165162358033 POUCH in 1 CARTON (65162-358-03) / 1 PATCH in 1 POUCH (65162-358-01) / 7 d in 1 PATCH
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A213950
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ethinyl Estradiol; Ethinyl Diacetate Tablet
Raw payload (JSON)
{
"unii": {
"unii": "423D2T571U",
"rxcui": "4124",
"inchikey": "BFPYWIDHMRZLRN-SLHNCBLASA-N",
"display_name": "ETHINYL ESTRADIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TRANSDERMAL",
"spl_meta": {
"fbbd12dd-c538-2869-e053-6294a90a1a38": {
"match": "brand_token",
"title": "ZAFEMY (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [AVKARE]",
"spl_version": "2",
"published_date": "2026-01-21"
}
},
"productid": "65162-358_4370e72b-f961-453e-ab06-5d933a6f5b50",
"productndc": "65162-358",
"dosage_form": "PATCH",
"orange_book": {
"appl_no": "213950",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG/24HR;0.15MG/24HR",
"product_no": "001",
"approval_date": "Feb 25, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; NORELGESTROMIN",
"shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
"shortage_status": "current",
"proprietary_name": "ZAFEMY",
"active_ingred_unit": "ug/d; ug/d",
"application_number": "ANDA213950",
"marketing_category": "ANDA",
"nonproprietary_name": "Norelgestromin and Ethinyl Estradiol",
"start_marketing_date": "20200628",
"active_numerator_strength": "35; 150"
}Related drugs
Other records sharing ATC code G03CA.
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