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United States · US · US:59651-713_50b05c90-bdd9-4766-b285-52bd88c4c740
Tretinoin
Orange BookUNIISPLATC D10AD51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeD10AD51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1159651713141 TUBE in 1 CARTON (59651-713-14) / 15 g in 1 TUBE
- ndc1159651713461 TUBE in 1 CARTON (59651-713-46) / 45 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
5688UTC01R
TRETINOIN
RxCUI 10753
Orange Book
A218245
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": {
"4b6006e3-f7a4-4823-8217-3e5b0f7e58d9": {
"match": "brand_token",
"title": "TRETINOIN GEL [AMNEAL PHARMACEUTICALS NY LLC]",
"spl_version": "7",
"published_date": "2026-05-20"
}
},
"productid": "59651-713_50b05c90-bdd9-4766-b285-52bd88c4c740",
"productndc": "59651-713",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "218245",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.025%",
"product_no": "001",
"approval_date": "Feb 27, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRETINOIN",
"proprietary_name": "Tretinoin",
"active_ingred_unit": "mg/g",
"application_number": "ANDA218245",
"marketing_category": "ANDA",
"nonproprietary_name": "Tretinoin",
"start_marketing_date": "20250227",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code D10AD51.
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