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United States · US · US:42794-083_f1f1dd05-77f9-ff40-e053-2995a90a2e80
ACITRETIN
Orange BookUNIISPLATC D05BB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSigmapharm Laboratories, LLC
CountryUS (United States)
ATC codeD05BB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11427940830830 CAPSULE in 1 BOTTLE (42794-083-08)
Annotations
UNII (FDA Substance ID)
LCH760E9T7
ACITRETIN
RxCUI 16818
Orange Book
A204633
ABABABAB
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": "42794-083_f1f1dd05-77f9-ff40-e053-2995a90a2e80",
"productndc": "42794-083",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204633",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 22, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "17.5MG",
"product_no": "002",
"approval_date": "May 22, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "22.5MG",
"product_no": "003",
"approval_date": "May 22, 2015"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "004",
"approval_date": "May 22, 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": "ANDA204633",
"marketing_category": "ANDA",
"nonproprietary_name": "ACITRETIN",
"start_marketing_date": "20150916",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code D05BB02.
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