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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020182-001 CARNITOR 200MG/ML INJECTABLE / INJECTION AP RLD, RS 1992-12-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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