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United States · US · US:51407-953_4b86e049-6e94-b8a6-e063-6294a90a1014
GUANFACINE
In shortageOrange BookUNIISPLATC C02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeC02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115140795301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-953-01)
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": "51407-953_4b86e049-6e94-b8a6-e063-6294a90a1014",
"productndc": "51407-953",
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217269",
"marketing_category": "ANDA",
"nonproprietary_name": "GUANFACINE",
"start_marketing_date": "20230807",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code C02AC02.
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