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United States · US · US:71671-100_722214f4-2c40-93f5-32ea-a297d82b32d0
Twirla
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAgile Therapeutics, Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1171671100011 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11)
- ndc1171671100033 POUCH in 1 CARTON (71671-100-03) / 1 PATCH in 1 POUCH (71671-100-11)
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
N204017
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": {
"bcaf8db0-1750-425d-b008-255b5e7a9cc6": {
"match": "brand_token",
"title": "TWIRLA (LEVONORGESTREL/ETHINYL ESTRADIOL) PATCH [AGILE THERAPEUTICS, INC.]",
"spl_version": "7",
"published_date": "2025-12-12"
}
},
"productid": "71671-100_722214f4-2c40-93f5-32ea-a297d82b32d0",
"productndc": "71671-100",
"dosage_form": "PATCH",
"orange_book": {
"appl_no": "204017",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.03MG/24HR;0.12MG/24HR",
"product_no": "001",
"approval_date": "Feb 14, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; LEVONORGESTREL",
"shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
"shortage_status": "current",
"proprietary_name": "Twirla",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA204017",
"marketing_category": "NDA",
"nonproprietary_name": "levonorgestrel/ethinyl estradiol",
"start_marketing_date": "20200911",
"active_numerator_strength": "2.3; 2.6"
}Related drugs
Other records sharing ATC code G03CA.
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