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United States · US · US:70954-492_d259f663-b597-48bd-8420-3b5774ffc204
Levocarnitine
Orange BookUNIISPLATC A16AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA16AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11709544921090 BLISTER PACK in 1 CARTON (70954-492-10) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
0G389FZZ9M
LEVOCARNITINE
RxCUI 42955
Orange Book
A216384
AB
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": {
"18dc8eae-56c1-46ec-9d21-e17d7b2f91db": {
"match": "brand_token",
"title": "LEVOCARNITINE SOLUTION [ANI PHARMACEUTICALS, INC.]",
"spl_version": "7",
"published_date": "2025-12-31"
}
},
"productid": "70954-492_d259f663-b597-48bd-8420-3b5774ffc204",
"productndc": "70954-492",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216384",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "330MG",
"product_no": "001",
"approval_date": "Dec 9, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOCARNITINE",
"proprietary_name": "Levocarnitine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216384",
"marketing_category": "ANDA",
"nonproprietary_name": "Levocarnitine",
"start_marketing_date": "20221209",
"active_numerator_strength": "330"
}Related drugs
Other records sharing ATC code A16AA01.
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