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United States · US · US:50633-220_4e4e69bd-abb4-4632-e063-6394a90ab642

VISTOGARD

Orange BookUNIISPLATC A16AX13

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

Identification

ManufacturerBTG International Inc
CountryUS (United States)
ATC codeA16AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5063322004
    4 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET (50633-220-10)
  • ndc11
    5063322020
    20 PACKET in 1 CARTON (50633-220-20) / 10 g in 1 PACKET (50633-220-10)

Annotations

UNII (FDA Substance ID)
2WP61F175M
URIDINE TRIACETATE
RxCUI 1665222
Orange Book
N208159
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2WP61F175M",
    "rxcui": "1665222",
    "inchikey": "AUFUWRKPQLGTGF-FMKGYKFTSA-N",
    "display_name": "URIDINE TRIACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "269f7363-63ed-444e-85f1-f0009e44818b": {
      "match": "brand_token",
      "title": "VISTOGARD (URIDINE TRIACETATE) GRANULE [BTG INTERNATIONAL INC]",
      "spl_version": "3",
      "published_date": "2026-04-14"
    }
  },
  "productid": "50633-220_4e4e69bd-abb4-4632-e063-6394a90ab642",
  "productndc": "50633-220",
  "dosage_form": "GRANULE",
  "orange_book": {
    "appl_no": "208159",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10GM/PACKET",
        "product_no": "001",
        "approval_date": "Dec 11, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "URIDINE TRIACETATE",
  "proprietary_name": "VISTOGARD",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA208159",
  "marketing_category": "NDA",
  "nonproprietary_name": "uridine triacetate",
  "start_marketing_date": "20240731",
  "active_numerator_strength": "951"
}

Related drugs

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