levocarnitine

Generic: levocarnitine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocarnitine
Generic Name levocarnitine
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levocarnitine 1 g/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9852
Product ID 0143-9852_1bc5a420-8884-4b82-a39b-02064a59fde4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075567
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439852
Hyphenated Format 0143-9852

Supplemental Identifiers

RxCUI
1791371
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 ANDA075567 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (0143-9852-10) / 5 mL in 1 VIAL, SINGLE-USE (0143-9852-01)
source: ndc

Packages (1)

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

Ingredients (1)

levocarnitine (1 g/5mL)

Linked Drug Pages (1)

Levocarnitine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1bc5a420-8884-4b82-a39b-02064a59fde4", "openfda": {"nui": ["M0003493", "N0000175903"], "unii": ["0G389FZZ9M"], "rxcui": ["1791371"], "spl_set_id": ["8f255df8-8a1f-4b4f-ae8c-2c80532ce8d4"], "pharm_class_cs": ["Carnitine [CS]"], "pharm_class_epc": ["Carnitine Analog [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (0143-9852-10)  / 5 mL in 1 VIAL, SINGLE-USE (0143-9852-01)", "package_ndc": "0143-9852-10", "marketing_start_date": "20230601"}], "brand_name": "Levocarnitine", "product_id": "0143-9852_1bc5a420-8884-4b82-a39b-02064a59fde4", "dosage_form": "INJECTION", "pharm_class": ["Carnitine Analog [EPC]", "Carnitine [CS]"], "product_ndc": "0143-9852", "generic_name": "Levocarnitine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocarnitine", "active_ingredients": [{"name": "LEVOCARNITINE", "strength": "1 g/5mL"}], "application_number": "ANDA075567", "marketing_category": "ANDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}