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United States · US · US:0143-9852_1bc5a420-8884-4b82-a39b-02064a59fde4

Levocarnitine

Orange BookUNIISPLATC A16AA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA16AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0143985210
    10 VIAL, SINGLE-USE in 1 CARTON (0143-9852-10) / 5 mL in 1 VIAL, SINGLE-USE (0143-9852-01)

Annotations

UNII (FDA Substance ID)
0G389FZZ9M
LEVOCARNITINE
RxCUI 42955
Orange Book
A075567
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": "0143-9852_1bc5a420-8884-4b82-a39b-02064a59fde4",
  "productndc": "0143-9852",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "075567",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/ML",
        "product_no": "001",
        "approval_date": "Mar 29, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOCARNITINE",
  "proprietary_name": "Levocarnitine",
  "active_ingred_unit": "g/5mL",
  "application_number": "ANDA075567",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levocarnitine",
  "start_marketing_date": "20230601",
  "active_numerator_strength": "1"
}

Related drugs

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