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United States · US · US:0555-0635_012ba27f-5410-4461-bc8a-72004ac311a6
Danazol
Orange BookUNIISPLATC G03XA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeG03XA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110555063502100 CAPSULE in 1 BOTTLE (0555-0635-02)
- ndc11055506350960 CAPSULE in 1 BOTTLE (0555-0635-09)
Annotations
UNII (FDA Substance ID)
N29QWW3BUO
DANAZOL
RxCUI 3102
Orange Book
A074582
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": "0555-0635_012ba27f-5410-4461-bc8a-72004ac311a6",
"productndc": "0555-0635",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "074582",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Aug 9, 1996"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "May 29, 1998"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "May 29, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DANAZOL",
"proprietary_name": "Danazol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA074582",
"marketing_category": "ANDA",
"nonproprietary_name": "Danazol",
"start_marketing_date": "19960809",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G03XA01.
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