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United States · US · US:70518-2771_4a8f6fe7-ff80-5bff-e063-6294a90a39ad
Guanfacine
In shortageOrange BookUNIISPLATC C02AC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC02AC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11705182771030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2771-0)
- ndc117051827711100 POUCH in 1 BOX (70518-2771-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2771-2)
Annotations
UNII (FDA Substance ID)
30OMY4G3MK
GUANFACINE
RxCUI 40114
Orange Book
A201408
ABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Guanfacine Hydrochloride Tablet, Extended Release
Raw payload (JSON)
{
"unii": {
"unii": "30OMY4G3MK",
"rxcui": "40114",
"inchikey": "INJOMKTZOLKMBF-UHFFFAOYSA-N",
"display_name": "GUANFACINE",
"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": "70518-2771_4a8f6fe7-ff80-5bff-e063-6294a90a39ad",
"productndc": "70518-2771",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "201408",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "001",
"approval_date": "Jun 2, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "002",
"approval_date": "Jun 2, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 3MG BASE",
"product_no": "003",
"approval_date": "Jun 2, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "004",
"approval_date": "Jun 2, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GUANFACINE",
"shortage_reason": "Guanfacine Hydrochloride Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "Guanfacine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201408",
"marketing_category": "ANDA",
"nonproprietary_name": "Guanfacine",
"start_marketing_date": "20200608",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C02AC02.
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