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United States · US · US:65976-100_668385ee-9443-4d20-b0ea-655c2526ca96
Arestin
Orange BookUNIISPLATC A01AB23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOraPharma, Inc.
CountryUS (United States)
ATC codeA01AB23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1165976100011 POWDER in 1 POUCH (65976-100-01)
- ndc1165976100121 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY
- ndc1165976100242 POUCH in 1 BOX (65976-100-24) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY
Annotations
UNII (FDA Substance ID)
0020414E5U
MINOCYCLINE HYDROCHLORIDE
RxCUI 6979
Orange Book
N050781
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0020414E5U",
"rxcui": "6979",
"inchikey": "GLMUAFMGXXHGLU-VQAITOIOSA-N",
"display_name": "MINOCYCLINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8515df41-1936-4f3b-86ba-d2bb2a8441fb": {
"match": "brand_token",
"title": "ARESTIN (MINOCYCLINE HYDROCHLORIDE) POWDER [ORAPHARMA, INC.]",
"spl_version": "21",
"published_date": "2024-08-16"
}
},
"productid": "65976-100_668385ee-9443-4d20-b0ea-655c2526ca96",
"productndc": "65976-100",
"dosage_form": "POWDER",
"orange_book": {
"appl_no": "050781",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Feb 16, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MINOCYCLINE HYDROCHLORIDE",
"proprietary_name": "Arestin",
"active_ingred_unit": "mg/1",
"application_number": "NDA050781",
"marketing_category": "NDA",
"nonproprietary_name": "Minocycline Hydrochloride",
"start_marketing_date": "20110321",
"active_numerator_strength": "1"
}Related drugs
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