Renacidin

Orange BookUNII

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerUnited-Guardian, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0327001230
30 BOTTLE in 1 CARTON (0327-0012-30) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

XF417D3PSL

ANHYDROUS CITRIC ACID

RxCUI 221946

Orange Book

N019481

Raw payload (JSON)

{
  "unii": {
    "unii": "XF417D3PSL",
    "rxcui": "221946",
    "inchikey": "KRKNYBCHXYNGOX-UHFFFAOYSA-N",
    "display_name": "ANHYDROUS CITRIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "IRRIGATION",
  "productid": "0327-0012_73bb8d15-8d5c-426c-b42f-504a5da9cb8e",
  "productndc": "0327-0012",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "019481",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "6.602GM/100ML;198MG/100ML;3.177GM/100ML",
        "product_no": "001",
        "approval_date": "Oct 2, 1990"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE",
  "proprietary_name": "Renacidin",
  "active_ingred_unit": "g/100mL; g/100mL; g/100mL",
  "application_number": "NDA019481",
  "marketing_category": "NDA",
  "nonproprietary_name": "citric acid, gluconolactone and magnesium carbonate",
  "start_marketing_date": "20160201",
  "active_numerator_strength": "6.602; .198; 3.268"
}

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