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United States · US · US:71205-947_6de48883-f40b-4aef-83d4-6acb86c1b11e

Guanfacine

In shortageOrange BookUNIISPLATC C02AC02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC02AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7120594700
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-00)
  • ndc11
    7120594730
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-30)
  • ndc11
    7120594755
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-55)
  • ndc11
    7120594760
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-60)
  • ndc11
    7120594790
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-90)

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": "71205-947_6de48883-f40b-4aef-83d4-6acb86c1b11e",
  "productndc": "71205-947",
  "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": "4"
}

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