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United States · US · US:83723-010_3f660131-556e-fa6f-e063-6294a90a3dec
Sofdra
Orange BookUNIISPLATC D11AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBotanix SB Inc.
CountryUS (United States)
ATC codeD11AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183723010501 BOTTLE in 1 CARTON (83723-010-50) / 50 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7B2Y1932XU
SOFPIRONIUM BROMIDE
Orange Book
N217347
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7B2Y1932XU",
"rxcui": null,
"inchikey": "FIAFMTCUJCWADZ-JOFREBOKSA-M",
"display_name": "SOFPIRONIUM BROMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"78f86f4f-658c-468b-bd54-49182ddcc7ac": {
"match": "brand_token",
"title": "SOFDRA (SOFPIRONIUM BROMIDE) GEL [BOTANIX SB INC.]",
"spl_version": "6",
"published_date": "2025-09-25"
}
},
"productid": "83723-010_3f660131-556e-fa6f-e063-6294a90a3dec",
"productndc": "83723-010",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "217347",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)",
"product_no": "001",
"approval_date": "Jun 18, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOFPIRONIUM BROMIDE",
"proprietary_name": "Sofdra",
"active_ingred_unit": "mg/.67mL",
"application_number": "NDA217347",
"marketing_category": "NDA",
"nonproprietary_name": "sofpironium bromide",
"start_marketing_date": "20240806",
"active_numerator_strength": "87"
}Related drugs
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