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United States · US · US:0378-7023_4e629ef9-879a-443d-9397-c47962855dd8
Acitretin
Orange BookUNIISPLATC D05BB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD05BB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037870239330 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93)
Annotations
UNII (FDA Substance ID)
LCH760E9T7
ACITRETIN
RxCUI 16818
Orange Book
A202148
ABAB
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": "0378-7023_4e629ef9-879a-443d-9397-c47962855dd8",
"productndc": "0378-7023",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202148",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 10, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Sep 10, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACITRETIN",
"proprietary_name": "Acitretin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202148",
"marketing_category": "ANDA",
"nonproprietary_name": "acitretin",
"start_marketing_date": "20160310",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code D05BB02.
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