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United States · US · US:72888-227_3383419f-2181-88f4-e063-6394a90a38bc
GUANFACINE
In shortageOrange BookUNIISPLATC C02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvagen Pharma Limited
CountryUS (United States)
ATC codeC02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1172888227001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-227-00)
- ndc117288822701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-227-01)
- ndc117288822705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-227-05)
- ndc11728882273030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-227-30)
Annotations
UNII (FDA Substance ID)
PML56A160O
GUANFACINE HYDROCHLORIDE
RxCUI 203142
Orange Book
A219689
ABABABAB
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": "72888-227_3383419f-2181-88f4-e063-6394a90a38bc",
"productndc": "72888-227",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "219689",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Apr 15, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Apr 15, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 3MG BASE",
"product_no": "003",
"approval_date": "Apr 15, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "004",
"approval_date": "Apr 15, 2025"
}
],
"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": "ANDA219689",
"marketing_category": "ANDA",
"nonproprietary_name": "GUANFACINE",
"start_marketing_date": "20250415",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code C02AC02.
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