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United States · US · US:70710-1494_b41c9be1-67c2-416e-ae53-5c31eafb8e10

vigabatrin

In shortageOrange BookUNIISPLATC N03AG04

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeN03AG04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7071014948
    50 PACKET in 1 CARTON (70710-1494-8) / 10 mL in 1 PACKET (70710-1494-1)

Annotations

UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A214671
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": "70710-1494_b41c9be1-67c2-416e-ae53-5c31eafb8e10",
  "productndc": "70710-1494",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214671",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG/PACKET",
        "product_no": "001",
        "approval_date": "Mar 2, 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": "vigabatrin",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA214671",
  "marketing_category": "ANDA",
  "nonproprietary_name": "vigabatrin",
  "start_marketing_date": "20250324",
  "active_numerator_strength": "500"
}

Related drugs

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