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United States · US · US:60687-710_20d4dc32-fa9a-d4dd-e063-6394a90a3861

Guanfacine Hydrochloride

In shortageOrange BookUNIISPLATC C02AC02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeC02AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068771021
    30 BLISTER PACK in 1 CARTON (60687-710-21) / 1 TABLET in 1 BLISTER PACK (60687-710-11)

Annotations

UNII (FDA Substance ID)
30OMY4G3MK
GUANFACINE
RxCUI 40114
Orange Book
A214689
ABAB
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": "60687-710_20d4dc32-fa9a-d4dd-e063-6394a90a3861",
  "productndc": "60687-710",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214689",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Mar 3, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Mar 3, 2021"
      }
    ],
    "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 Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214689",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guanfacine Hydrochloride",
  "start_marketing_date": "20231109",
  "active_numerator_strength": "1"
}

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