Guanfacine Hydrochloride

In shortageOrange BookUNIISPLATC C02AC02

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.

CountryUS (United States)

ATC codeC02AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2930045901
100 TABLET in 1 BOTTLE (29300-459-01)

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": "29300-459_9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3",
  "productndc": "29300-459",
  "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": "20210303",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code C02AC02.

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