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United States · US · US:59651-840_e6d4fc3d-4169-44f1-bcb9-1188de40d4e5
GUANFACINE
In shortageOrange BookUNIISPLATC C02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115965184001100 TABLET in 1 BOTTLE (59651-840-01)
Annotations
UNII (FDA Substance ID)
PML56A160O
GUANFACINE HYDROCHLORIDE
RxCUI 203142
Orange Book
A074796
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Guanfacine Hydrochloride Tablet, Extended Release
Raw payload (JSON)
{
"unii": {
"unii": "PML56A160O",
"rxcui": "203142",
"inchikey": "DGFYECXYGUIODH-UHFFFAOYSA-N",
"display_name": "GUANFACINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6006df06-0448-462d-b81e-7add50a6d71b": {
"match": "brand_token",
"title": "GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "12",
"published_date": "2026-06-01"
}
},
"productid": "59651-840_e6d4fc3d-4169-44f1-bcb9-1188de40d4e5",
"productndc": "59651-840",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "074796",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Jan 27, 1997"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Jan 27, 1997"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GUANFACINE HYDROCHLORIDE",
"shortage_reason": "Guanfacine Hydrochloride Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "GUANFACINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA074796",
"marketing_category": "ANDA",
"nonproprietary_name": "GUANFACINE HYDROCHLORIDE",
"start_marketing_date": "20230807",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C02AC02.
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