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United States · US · US:0378-8082_96edaee2-b74e-4f7b-947f-1addc75402ea
Tretinoin
Orange BookUNIISPLATC D10AD51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD10AD51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1103788082201 TUBE in 1 CARTON (0378-8082-20) / 20 g in 1 TUBE
- ndc1103788082451 TUBE in 1 CARTON (0378-8082-45) / 45 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
5688UTC01R
TRETINOIN
RxCUI 10753
Orange Book
N019049
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": "0378-8082_96edaee2-b74e-4f7b-947f-1addc75402ea",
"productndc": "0378-8082",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "019049",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.025%",
"product_no": "001",
"approval_date": "Sep 16, 1988"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRETINOIN",
"proprietary_name": "Tretinoin",
"active_ingred_unit": "mg/g",
"application_number": "NDA019049",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Tretinoin",
"start_marketing_date": "20190403",
"active_numerator_strength": ".25"
}Related drugs
Other records sharing ATC code D10AD51.
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