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United States · US · US:68308-777_7c0103a9-019d-4bc4-b4f5-df7d89bfd11d
Tretinoin (Microsphere)
Orange BookUNIISPLATC D10AD51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma
CountryUS (United States)
ATC codeD10AD51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168308777501 BOTTLE, PUMP in 1 CARTON (68308-777-50) / 50 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
5688UTC01R
TRETINOIN
RxCUI 10753
Orange Book
A215609
ABAB
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": "68308-777_7c0103a9-019d-4bc4-b4f5-df7d89bfd11d",
"productndc": "68308-777",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "215609",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.08%",
"product_no": "001",
"approval_date": "Aug 22, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.06%",
"product_no": "002",
"approval_date": "Apr 15, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRETINOIN",
"proprietary_name": "Tretinoin (Microsphere)",
"active_ingred_unit": "mg/g",
"application_number": "ANDA215609",
"marketing_category": "ANDA",
"nonproprietary_name": "tretinoin",
"start_marketing_date": "20241025",
"active_numerator_strength": ".8"
}Related drugs
Other records sharing ATC code D10AD51.
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