Guanfacine

In shortageOrange BookUNIISPLATC C02AC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNORTHSTAR RXLLC

CountryUS (United States)

ATC codeC02AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1671419201
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-192-01)

Annotations

UNII (FDA Substance ID)

PML56A160O

GUANFACINE HYDROCHLORIDE

RxCUI 203142

Orange Book

A205689

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": "16714-192_2a3f66a1-c942-7bba-e063-6394a90a05a1",
  "productndc": "16714-192",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205689",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 3MG BASE",
        "product_no": "003",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "004",
        "approval_date": "Nov 16, 2017"
      }
    ],
    "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": "ANDA205689",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guanfacine",
  "start_marketing_date": "20210917",
  "active_numerator_strength": "3"
}

Related drugs

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