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United States · US · US:54482-145_c1636127-9b6a-4443-81d9-e2607ae46e33
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 · 2
- ndc11544821450824 BOTTLE, PLASTIC in 1 CASE (54482-145-08) / 118 mL in 1 BOTTLE, PLASTIC
- ndc11544821450924 BOTTLE, PLASTIC in 1 CASE (54482-145-09) / 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": "54482-145_c1636127-9b6a-4443-81d9-e2607ae46e33",
"productndc": "54482-145",
"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",
"active_ingred_unit": "g/10mL",
"application_number": "NDA019257",
"marketing_category": "NDA",
"nonproprietary_name": "levocarnitine",
"start_marketing_date": "19860410",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A16AA01.
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