Back to search
🇺🇸

United States · US · US:0245-6001_2734e899-4ddc-836c-e063-6294a90a128f

VIGADRONE

In shortageOrange BookUNIISPLATC N03AG04

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeN03AG04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0245600111
    1 BOTTLE in 1 CARTON (0245-6001-11) / 100 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A214749
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Vigabatrin Oral Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "GR120KRT6K",
    "rxcui": "14851",
    "inchikey": "PJDFLNIOAUIZSL-UHFFFAOYSA-N",
    "display_name": "VIGABATRIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5e5e7554-d0f4-47f7-a434-cc5ca5a9826f": {
      "match": "brand_token",
      "title": "VIGADRONE (VIGABATRIN) POWDER, FOR SOLUTION [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "8",
      "published_date": "2025-07-28"
    }
  },
  "productid": "0245-6001_2734e899-4ddc-836c-e063-6294a90a128f",
  "productndc": "0245-6001",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214749",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jun 29, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VIGABATRIN",
  "shortage_reason": "Vigabatrin Oral Solution",
  "shortage_status": "current",
  "proprietary_name": "VIGADRONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214749",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vigabatrin",
  "start_marketing_date": "20230629",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code N03AG04.

Access this data programmatically

Query VIGADRONE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.