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United States · US · US:24979-536_6634768f-1e5a-4604-9587-fe5ffbd7e331

Guanfacine

In shortageOrange BookUNIISPLATC C02AC02

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeC02AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2497953600
    100000 TABLET, EXTENDED RELEASE in 1 DRUM (24979-536-00)
  • ndc11
    2497953601
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-536-01)
  • ndc11
    2497953610
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-536-10)

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": "24979-536_6634768f-1e5a-4604-9587-fe5ffbd7e331",
  "productndc": "24979-536",
  "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": "20170707",
  "active_numerator_strength": "3"
}

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