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United States · US · US:54482-147_0a9cb8a2-c17d-9bd3-e063-6294a90ac0e0

Carnitor

Orange BookUNIISPLATC A16AA01

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

Identification

ManufacturerLeadiant Biosciences, Inc.
CountryUS (United States)
ATC codeA16AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5448214701
    5 VIAL in 1 CARTON (54482-147-01) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
0G389FZZ9M
LEVOCARNITINE
RxCUI 42955
Orange Book
N020182
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0G389FZZ9M",
    "rxcui": "42955",
    "inchikey": "PHIQHXFUZVPYII-ZCFIWIBFSA-N",
    "display_name": "LEVOCARNITINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d2133bc3-9c15-48bd-8b16-b8995a6a14cd": {
      "match": "brand_token",
      "title": "CARNITOR (LEVOCARNITINE) TABLET [LEADIANT BIOSCIENCES, INC.]",
      "spl_version": "21",
      "published_date": "2024-11-14"
    }
  },
  "productid": "54482-147_0a9cb8a2-c17d-9bd3-e063-6294a90ac0e0",
  "productndc": "54482-147",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020182",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "200MG/ML",
        "product_no": "001",
        "approval_date": "Dec 16, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOCARNITINE",
  "proprietary_name": "Carnitor",
  "active_ingred_unit": "g/5mL",
  "application_number": "NDA020182",
  "marketing_category": "NDA",
  "nonproprietary_name": "levocarnitine",
  "start_marketing_date": "19921216",
  "active_numerator_strength": "1"
}

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