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United States · US · US:54482-148_88041d93-8f95-4551-bba1-df964b092504

Carnitor SF

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 · 2

  • ndc11
    5448214801
    24 BOTTLE, PLASTIC in 1 CASE (54482-148-01) / 118 mL in 1 BOTTLE, PLASTIC
  • ndc11
    5448214802
    24 BOTTLE, PLASTIC in 1 CASE (54482-148-02) / 118 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
0G389FZZ9M
LEVOCARNITINE
RxCUI 42955
Orange Book
N019257
AAAA
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": "ORAL",
  "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": "54482-148_88041d93-8f95-4551-bba1-df964b092504",
  "productndc": "54482-148",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "019257",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "1GM/10ML",
        "product_no": "001",
        "approval_date": "Apr 10, 1986"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "1GM/10ML",
        "product_no": "002",
        "approval_date": "Mar 28, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOCARNITINE",
  "proprietary_name": "Carnitor SF",
  "active_ingred_unit": "g/10mL",
  "application_number": "NDA019257",
  "marketing_category": "NDA",
  "nonproprietary_name": "levocarnitine",
  "start_marketing_date": "19860410",
  "active_numerator_strength": "1"
}

Related drugs

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