levocarnitine

Generic: levocarnitine

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocarnitine
Generic Name levocarnitine
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levocarnitine 200 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-1045
Product ID 0517-1045_114eaeda-8965-4c92-a3ff-15021b305464
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075861
Listing Expiration 2026-12-31
Marketing Start 2023-06-21

Pharmacologic Class

Established (EPC)
carnitine analog [epc]
Chemical Structure
carnitine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05171045
Hyphenated Format 0517-1045

Supplemental Identifiers

RxCUI
1791371 2673428
UNII
0G389FZZ9M
NUI
M0003493 N0000175903

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name levocarnitine (source: ndc)
Generic Name levocarnitine (source: ndc)
Application Number ANDA075861 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1045-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01)
source: ndc

Packages (1)

0517-1045-05 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1045-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01)

Ingredients (1)

levocarnitine (200 mg/mL)

Linked Drug Pages (1)

Levocarnitine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "114eaeda-8965-4c92-a3ff-15021b305464", "openfda": {"nui": ["M0003493", "N0000175903"], "unii": ["0G389FZZ9M"], "rxcui": ["1791371", "2673428"], "spl_set_id": ["cc4da2c3-f939-444d-9b5b-a57b6051c190"], "pharm_class_cs": ["Carnitine [CS]"], "pharm_class_epc": ["Carnitine Analog [EPC]"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1045-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01)", "package_ndc": "0517-1045-05", "marketing_start_date": "20230621"}], "brand_name": "Levocarnitine", "product_id": "0517-1045_114eaeda-8965-4c92-a3ff-15021b305464", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Carnitine Analog [EPC]", "Carnitine [CS]"], "product_ndc": "0517-1045", "generic_name": "Levocarnitine", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocarnitine", "active_ingredients": [{"name": "LEVOCARNITINE", "strength": "200 mg/mL"}], "application_number": "ANDA075861", "marketing_category": "ANDA", "marketing_start_date": "20230621", "listing_expiration_date": "20261231"}