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United States · US · US:16571-762_ad6d92d4-71c1-481a-a7cf-b2d551c5daad

Levocarnitine

Orange BookUNIISPLATC A16AA01

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA16AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1657176209
    9 BLISTER PACK in 1 CARTON (16571-762-09) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
0G389FZZ9M
LEVOCARNITINE
RxCUI 42955
Orange Book
A076858
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": "16571-762_ad6d92d4-71c1-481a-a7cf-b2d551c5daad",
  "productndc": "16571-762",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076858",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "330MG",
        "product_no": "001",
        "approval_date": "Sep 20, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOCARNITINE",
  "proprietary_name": "Levocarnitine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076858",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levocarnitine",
  "start_marketing_date": "20201201",
  "active_numerator_strength": "330"
}

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