Levocarnitine

Orange BookUNIISPLATC A16AA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSaptalis Pharmaceuticals, LLC

CountryUS (United States)

ATC codeA16AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7165601601
100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)
ndc11
7165601602
100 CUP, UNIT-DOSE in 1 TRAY (71656-016-02) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)
ndc11
7165601604
118 mL in 1 BOTTLE (71656-016-04)
ndc11
7165601650
50 CUP, UNIT-DOSE in 1 TRAY (71656-016-50) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)
ndc11
7165601651
50 CUP, UNIT-DOSE in 1 TRAY (71656-016-51) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)

Annotations

UNII (FDA Substance ID)

0G389FZZ9M

LEVOCARNITINE

RxCUI 42955

Orange Book

A212533

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": "71656-016_30a343cc-caab-d417-e063-6394a90ad77b",
  "productndc": "71656-016",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "212533",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1GM/10ML",
        "product_no": "001",
        "approval_date": "Nov 10, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOCARNITINE",
  "proprietary_name": "Levocarnitine",
  "active_ingred_unit": "g/10mL",
  "application_number": "ANDA212533",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levocarnitine Oral",
  "start_marketing_date": "20240221",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A16AA01.

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