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United States · US · US:0115-1751_233bc68a-a24e-4f19-8477-3a11e80e68df
Acitretin
Orange BookUNIISPLATC D05BB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeD05BB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11011517510830 CAPSULE in 1 BOTTLE, PLASTIC (0115-1751-08)
Annotations
UNII (FDA Substance ID)
LCH760E9T7
ACITRETIN
RxCUI 16818
Orange Book
A202552
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": "0115-1751_233bc68a-a24e-4f19-8477-3a11e80e68df",
"productndc": "0115-1751",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202552",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Dec 23, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "17.5MG",
"product_no": "002",
"approval_date": "Dec 23, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "22.5MG",
"product_no": "003",
"approval_date": "Dec 23, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "004",
"approval_date": "Dec 23, 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": "ANDA202552",
"marketing_category": "ANDA",
"nonproprietary_name": "Acitretin",
"start_marketing_date": "20160104",
"active_numerator_strength": "17.5"
}Related drugs
Other records sharing ATC code D05BB02.
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