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United States · US · US:69499-501_c0176981-bd6e-480f-9167-80555050b025

QUIOFIC

Orange BookUNIISPLATC V04CX02

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

Identification

ManufacturerSolubiomix, LLC
CountryUS (United States)
ATC codeV04CX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6949950175
    75 mL in 1 BOTTLE (69499-501-75)

Annotations

UNII (FDA Substance ID)
935E97BOY8
FOLIC ACID
RxCUI 4511
Orange Book
N216395
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "935E97BOY8",
    "rxcui": "4511",
    "inchikey": "OVBPIULPVIDEAO-LBPRGKRZSA-N",
    "display_name": "FOLIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b868b314-591d-458b-be82-2bcd0b73cce1": {
      "match": "brand_token",
      "title": "QUIOFIC (FOLIC ACID) SOLUTION [SOLUBIOMIX, LLC]",
      "spl_version": "3",
      "published_date": "2026-02-10"
    }
  },
  "productid": "69499-501_c0176981-bd6e-480f-9167-80555050b025",
  "productndc": "69499-501",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "216395",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.2MG/ML",
        "product_no": "001",
        "approval_date": "Jan 26, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOLIC ACID",
  "proprietary_name": "QUIOFIC",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA216395",
  "marketing_category": "NDA",
  "nonproprietary_name": "folic acid",
  "start_marketing_date": "20260128",
  "active_numerator_strength": "1"
}

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