levocarnitine

Generic: levocarnitine oral

Labeler: saptalis pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocarnitine
Generic Name levocarnitine oral
Labeler saptalis pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levocarnitine 1 g/10mL

Manufacturer
Saptalis Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 71656-016
Product ID 71656-016_30a343cc-caab-d417-e063-6394a90ad77b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212533
Listing Expiration 2026-12-31
Marketing Start 2024-02-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71656016
Hyphenated Format 71656-016

Supplemental Identifiers

RxCUI
315134
UPC
0371656016043
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 oral (source: ndc)
Application Number ANDA212533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)
  • 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-02) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)
  • 118 mL in 1 BOTTLE (71656-016-04)
  • 50 CUP, UNIT-DOSE in 1 TRAY (71656-016-50) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)
  • 50 CUP, UNIT-DOSE in 1 TRAY (71656-016-51) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)
source: ndc

Packages (5)

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

Ingredients (1)

levocarnitine (1 g/10mL)

Linked Drug Pages (1)

Levocarnitine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30a343cc-caab-d417-e063-6394a90ad77b", "openfda": {"nui": ["M0003493", "N0000175903"], "upc": ["0371656016043"], "unii": ["0G389FZZ9M"], "rxcui": ["315134"], "spl_set_id": ["75b43fb1-4486-48a0-b571-7754dce350a3"], "pharm_class_cs": ["Carnitine [CS]"], "pharm_class_epc": ["Carnitine Analog [EPC]"], "manufacturer_name": ["Saptalis Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01)  / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)", "package_ndc": "71656-016-01", "marketing_start_date": "20240221"}, {"sample": false, "description": "100 CUP, UNIT-DOSE in 1 TRAY (71656-016-02)  / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)", "package_ndc": "71656-016-02", "marketing_start_date": "20240221"}, {"sample": false, "description": "118 mL in 1 BOTTLE (71656-016-04)", "package_ndc": "71656-016-04", "marketing_start_date": "20240221"}, {"sample": false, "description": "50 CUP, UNIT-DOSE in 1 TRAY (71656-016-50)  / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)", "package_ndc": "71656-016-50", "marketing_start_date": "20240221"}, {"sample": false, "description": "50 CUP, UNIT-DOSE in 1 TRAY (71656-016-51)  / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)", "package_ndc": "71656-016-51", "marketing_start_date": "20240221"}], "brand_name": "Levocarnitine", "product_id": "71656-016_30a343cc-caab-d417-e063-6394a90ad77b", "dosage_form": "SOLUTION", "pharm_class": ["Carnitine Analog [EPC]", "Carnitine [CS]"], "product_ndc": "71656-016", "generic_name": "Levocarnitine Oral", "labeler_name": "Saptalis Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocarnitine", "active_ingredients": [{"name": "LEVOCARNITINE", "strength": "1 g/10mL"}], "application_number": "ANDA212533", "marketing_category": "ANDA", "marketing_start_date": "20240221", "listing_expiration_date": "20261231"}