levocarnitine

Generic: levocarnitine

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocarnitine
Generic Name levocarnitine
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levocarnitine 330 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-492
Product ID 70954-492_d259f663-b597-48bd-8420-3b5774ffc204
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216384
Listing Expiration 2026-12-31
Marketing Start 2022-12-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954492
Hyphenated Format 70954-492

Supplemental Identifiers

RxCUI
197448
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 ANDA216384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 330 mg/1
source: ndc
Packaging
  • 90 BLISTER PACK in 1 CARTON (70954-492-10) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70954-492-10 90 BLISTER PACK in 1 CARTON (70954-492-10) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

levocarnitine (330 mg/1)

Linked Drug Pages (1)

Levocarnitine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d259f663-b597-48bd-8420-3b5774ffc204", "openfda": {"nui": ["M0003493", "N0000175903"], "unii": ["0G389FZZ9M"], "rxcui": ["197448"], "spl_set_id": ["bfd0d39f-d3b2-4f0d-b7a2-071a545900f4"], "pharm_class_cs": ["Carnitine [CS]"], "pharm_class_epc": ["Carnitine Analog [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 BLISTER PACK in 1 CARTON (70954-492-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70954-492-10", "marketing_start_date": "20221209"}], "brand_name": "Levocarnitine", "product_id": "70954-492_d259f663-b597-48bd-8420-3b5774ffc204", "dosage_form": "TABLET", "pharm_class": ["Carnitine Analog [EPC]", "Carnitine [CS]"], "product_ndc": "70954-492", "generic_name": "Levocarnitine", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocarnitine", "active_ingredients": [{"name": "LEVOCARNITINE", "strength": "330 mg/1"}], "application_number": "ANDA216384", "marketing_category": "ANDA", "marketing_start_date": "20221209", "listing_expiration_date": "20261231"}