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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

  • ndc11
    0517107501
    1 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

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