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United States · US · US:0591-3128_aacccc63-aa7d-435e-bec5-0aab0e04153f
PROGESTERONE
In shortageOrange BookUNIISPLATC G03DA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeG03DA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11059131287910 mL in 1 VIAL, MULTI-DOSE (0591-3128-79)
Annotations
UNII (FDA Substance ID)
4G7DS2Q64Y
PROGESTERONE
RxCUI 8727
Orange Book
N017362
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": "INTRAMUSCULAR",
"spl_meta": {
"41b3c3a7-5fb8-4451-a96c-2bd02613c021": {
"match": "brand_token",
"title": "PROGESTERONE CAPSULE [BIONPHARMA INC.]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "0591-3128_aacccc63-aa7d-435e-bec5-0aab0e04153f",
"productndc": "0591-3128",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "017362",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROGESTERONE",
"shortage_reason": "Progesterone Vaginal Gel",
"shortage_status": "current",
"proprietary_name": "PROGESTERONE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA017362",
"marketing_category": "NDA",
"nonproprietary_name": "PROGESTERONE",
"start_marketing_date": "19780511",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G03DA04.
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