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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

  • ndc11
    7218959730
    30 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"
}

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