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United States · US · US:69238-1424_96ae1401-5893-4af6-9e78-b7ec25ef42ff

Vigabatrin

In shortageOrange BookUNIISPLATC N03AG04

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeN03AG04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6923814241
    100 TABLET in 1 BOTTLE (69238-1424-1)

Annotations

UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A210042
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": {
    "e7cbc0a5-8c28-4451-9176-b608e228ba66": {
      "match": "brand_token",
      "title": "VIGABATRIN POWDER, FOR SOLUTION [PAR HEALTH USA, LLC]",
      "spl_version": "29",
      "published_date": "2026-04-23"
    }
  },
  "productid": "69238-1424_96ae1401-5893-4af6-9e78-b7ec25ef42ff",
  "productndc": "69238-1424",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210042",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jun 22, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VIGABATRIN",
  "shortage_reason": "Vigabatrin Oral Solution",
  "shortage_status": "current",
  "proprietary_name": "Vigabatrin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210042",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vigabatrin",
  "start_marketing_date": "20220627",
  "active_numerator_strength": "500"
}

Related drugs

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