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United States · US · US:70700-201_5264f1f1-0a2d-1506-22f5-71074729ece9
Progesterone vaginal insert
In shortageOrange BookUNIISPLATC G03DA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXIROMED, LLC
CountryUS (United States)
ATC codeG03DA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170700201701 CARTON in 1 CARTON (70700-201-70) / 21 BLISTER PACK in 1 CARTON (70700-201-69) / 1 INSERT in 1 BLISTER PACK (70700-201-68)
Annotations
UNII (FDA Substance ID)
4G7DS2Q64Y
PROGESTERONE
RxCUI 8727
Orange Book
A218391
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Progesterone Vaginal Gel
Raw payload (JSON)
{
"unii": {
"unii": "4G7DS2Q64Y",
"rxcui": "8727",
"inchikey": "RJKFOVLPORLFTN-LEKSSAKUSA-N",
"display_name": "PROGESTERONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "VAGINAL",
"spl_meta": {
"41b3c3a7-5fb8-4451-a96c-2bd02613c021": {
"match": "brand_token",
"title": "PROGESTERONE CAPSULE [BIONPHARMA INC.]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "70700-201_5264f1f1-0a2d-1506-22f5-71074729ece9",
"productndc": "70700-201",
"dosage_form": "INSERT",
"orange_book": {
"appl_no": "218391",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Sep 19, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROGESTERONE",
"shortage_reason": "Progesterone Vaginal Gel",
"shortage_status": "current",
"proprietary_name": "Progesterone vaginal insert",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218391",
"marketing_category": "ANDA",
"nonproprietary_name": "Progesterone",
"start_marketing_date": "20250923",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G03DA04.
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