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United States · US · US:0517-1075_114eaeda-8965-4c92-a3ff-15021b305464
Levocarnitine
Orange BookUNIISPLATC A16AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeA16AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105171075011 VIAL, SINGLE-DOSE in 1 CARTON (0517-1075-01) / 20 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
0G389FZZ9M
LEVOCARNITINE
RxCUI 42955
Orange Book
A075861
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": {
"18dc8eae-56c1-46ec-9d21-e17d7b2f91db": {
"match": "brand_token",
"title": "LEVOCARNITINE SOLUTION [ANI PHARMACEUTICALS, INC.]",
"spl_version": "7",
"published_date": "2025-12-31"
}
},
"productid": "0517-1075_114eaeda-8965-4c92-a3ff-15021b305464",
"productndc": "0517-1075",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "075861",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/ML",
"product_no": "001",
"approval_date": "Jun 22, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOCARNITINE",
"proprietary_name": "Levocarnitine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075861",
"marketing_category": "ANDA",
"nonproprietary_name": "Levocarnitine",
"start_marketing_date": "20230621",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code A16AA01.
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