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United States · US · US:63323-261_e03e68a3-f9df-4c3f-bd1f-30fae68433f3
Progesterone
In shortageOrange BookUNIISPLATC G03DA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeG03DA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323261101 VIAL, MULTI-DOSE in 1 CARTON (63323-261-10) / 10 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
4G7DS2Q64Y
PROGESTERONE
RxCUI 8727
Orange Book
A075906
AO
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": "63323-261_e03e68a3-f9df-4c3f-bd1f-30fae68433f3",
"productndc": "63323-261",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "075906",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Apr 25, 2001"
}
],
"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",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075906",
"marketing_category": "ANDA",
"nonproprietary_name": "PROGESTERONE",
"start_marketing_date": "20010719",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G03DA04.
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