Home NDC 54482-147 Carnitor
Product NDC 54482-147
11-digit product format 544820147
Labeler code 54482
Product ID 54482-147_0a9cb8a2-c17d-9bd3-e063-6294a90ac0e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levocarnitine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Leadiant Biosciences, Inc.
Application NDA020182
Marketing category NDA
Marketing start 1992-12-16
Substance LEVOCARNITINE
Active strength 1 g/5mL
Pharmacologic classes Carnitine Analog [EPC], Carnitine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020182-001 CARNITOR LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020182-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N020182-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Carnitor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCARNITINE 1 g/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0G389FZZ9M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 206345 Internal RxNorm lookup 1791371 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54482-147-01 Carnitor 5 in 1 CARTON INJECTION, SOLUTION 5 19 54482-147-01 Carnitor 5 mL in 1 VIAL INJECTION, SOLUTION 5 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOCARNITINE ACTIVE INGREDIENT 0G389FZZ9M CARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.] 8 LEVOCARNITINE ACTIVE MOIETY 0G389FZZ9M CARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.] 8 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.] 8 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.] 8 WATER INACTIVE INGREDIENT 059QF0KO0R CARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54482-147 CARNITOR (LEVOCARNITINE) INJECTION, SOLUTION [LEADIANT BIOSCIENCES, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20231122_cf801cc4-775e-433d-9d32-e5d9a98981d3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54482-147-01 54482014701 5 VIAL in 1 CARTON (54482-147-01) / 5 mL in 1 VIAL 5 vial 1992-12-16 0000-00-00 No No Current