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United States · US · US:52276-312_7238020c-dcef-42ca-947b-6162e1488608

Carbaglu

Orange BookUNIISPLATC A16AA05

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

Identification

ManufacturerRecordati Rare Diseases
CountryUS (United States)
ATC codeA16AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5227631205
    5 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05)
  • ndc11
    5227631260
    60 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60)

Annotations

UNII (FDA Substance ID)
5L0HB4V1EW
CARGLUMIC ACID
RxCUI 401713
Orange Book
N022562
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5L0HB4V1EW",
    "rxcui": "401713",
    "inchikey": "LCQLHJZYVOQKHU-VKHMYHEASA-N",
    "display_name": "CARGLUMIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "10175e73-5172-4dde-a508-8a88b7afc0a1": {
      "match": "brand_token",
      "title": "CARBAGLU (CARGLUMIC ACID) TABLET, FOR SUSPENSION [RECORDATI RARE DISEASES]",
      "spl_version": "36",
      "published_date": "2024-01-31"
    }
  },
  "productid": "52276-312_7238020c-dcef-42ca-947b-6162e1488608",
  "productndc": "52276-312",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "022562",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Mar 18, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARGLUMIC ACID",
  "proprietary_name": "Carbaglu",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022562",
  "marketing_category": "NDA",
  "nonproprietary_name": "Carglumic Acid",
  "start_marketing_date": "20100318",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code A16AA05.

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