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United States · US · US:13548-070_77e095d6-f941-44ef-ad04-08d607843d65
Atralin
Orange BookUNIISPLATC D10AD51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeD10AD51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1113548070451 TUBE in 1 PACKAGE (13548-070-45) / 45 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
5688UTC01R
TRETINOIN
RxCUI 10753
Orange Book
N022070
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5688UTC01R",
"rxcui": "10753",
"inchikey": "SHGAZHPCJJPHSC-YCNIQYBTSA-N",
"display_name": "TRETINOIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"b6b45969-a64a-4ce3-b3b6-157d2568a301": {
"match": "brand_token",
"title": "ATRALIN (TRETINOIN) GEL [BAUSCH HEALTH US, LLC]",
"spl_version": "10",
"published_date": "2025-09-03"
}
},
"productid": "13548-070_77e095d6-f941-44ef-ad04-08d607843d65",
"productndc": "13548-070",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "022070",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Jul 26, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRETINOIN",
"proprietary_name": "Atralin",
"active_ingred_unit": "g/100g",
"application_number": "NDA022070",
"marketing_category": "NDA",
"nonproprietary_name": "Tretinoin",
"start_marketing_date": "20070726",
"active_numerator_strength": ".05"
}Related drugs
Other records sharing ATC code D10AD51.
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