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United States · US · US:71205-862_9e103cf9-f075-48ba-8913-2e44f9442781
Danazol
Orange BookUNIISPLATC G03XA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG03XA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117120586200100 CAPSULE in 1 BOTTLE (71205-862-00)
- ndc11712058623030 CAPSULE in 1 BOTTLE (71205-862-30)
- ndc117120586255500 CAPSULE in 1 BOTTLE (71205-862-55)
- ndc11712058626060 CAPSULE in 1 BOTTLE (71205-862-60)
- ndc117120586272120 CAPSULE in 1 BOTTLE (71205-862-72)
- ndc11712058629090 CAPSULE in 1 BOTTLE (71205-862-90)
Annotations
UNII (FDA Substance ID)
N29QWW3BUO
DANAZOL
RxCUI 3102
Orange Book
A077246
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N29QWW3BUO",
"rxcui": "3102",
"inchikey": "POZRVZJJTULAOH-LHZXLZLDSA-N",
"display_name": "DANAZOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e19acee5-ff33-45a5-bbbf-801756bc59b4": {
"match": "brand_token",
"title": "DANAZOL CAPSULE [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "15",
"published_date": "2025-03-24"
}
},
"productid": "71205-862_9e103cf9-f075-48ba-8913-2e44f9442781",
"productndc": "71205-862",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "077246",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Sep 28, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Apr 19, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Apr 19, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DANAZOL",
"proprietary_name": "Danazol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077246",
"marketing_category": "ANDA",
"nonproprietary_name": "Danazol",
"start_marketing_date": "20050928",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G03XA01.
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