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United States · US · US:72189-597_286214e2-a65c-f43b-e063-6394a90a33be
Guanfacine ER
In shortageOrange BookUNIISPLATC C02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_rx
CountryUS (United States)
ATC codeC02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11721895973030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-597-30)
Annotations
UNII (FDA Substance ID)
PML56A160O
GUANFACINE HYDROCHLORIDE
RxCUI 203142
Orange Book
A217269
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": "72189-597_286214e2-a65c-f43b-e063-6394a90a33be",
"productndc": "72189-597",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "217269",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Aug 7, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Aug 7, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 3MG BASE",
"product_no": "003",
"approval_date": "Aug 7, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "004",
"approval_date": "Aug 7, 2023"
}
],
"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 ER",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217269",
"marketing_category": "ANDA",
"nonproprietary_name": "Guanfacine ER",
"start_marketing_date": "20241203",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C02AC02.
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