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United States · US · US:43598-651_f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74

Vigabatrin

In shortageOrange BookUNIISPLATC N03AG04

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

Identification

ManufacturerDr. Reddy�s Laboratories Inc.,
CountryUS (United States)
ATC codeN03AG04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4359865101
    100 TABLET, FILM COATED in 1 BOTTLE (43598-651-01)

Annotations

UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A211539
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": {
    "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": "43598-651_f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74",
  "productndc": "43598-651",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211539",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jan 29, 2021"
      }
    ],
    "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": "ANDA211539",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vigabatrin",
  "start_marketing_date": "20210201",
  "active_numerator_strength": "500"
}

Related drugs

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