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United States · US · US:46708-742_77011f2b-a2e7-4a43-9ff3-29d73f322319
Acitretin
Orange BookUNIISPLATC D05BB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeD05BB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11467087423030 CAPSULE in 1 BOTTLE (46708-742-30)
Annotations
UNII (FDA Substance ID)
LCH760E9T7
ACITRETIN
RxCUI 16818
Orange Book
A217774
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "LCH760E9T7",
"rxcui": "16818",
"inchikey": "IHUNBGSDBOWDMA-AQFIFDHZSA-N",
"display_name": "ACITRETIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"993a5325-cd10-4450-b5ea-1c0a90510df6": {
"match": "brand_token",
"title": "ACITRETIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "15",
"published_date": "2025-09-29"
}
},
"productid": "46708-742_77011f2b-a2e7-4a43-9ff3-29d73f322319",
"productndc": "46708-742",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217774",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Aug 5, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "17.5MG",
"product_no": "002",
"approval_date": "Aug 5, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Aug 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACITRETIN",
"proprietary_name": "Acitretin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217774",
"marketing_category": "ANDA",
"nonproprietary_name": "Acitretin",
"start_marketing_date": "20240808",
"active_numerator_strength": "17.5"
}Related drugs
Other records sharing ATC code D05BB02.
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