Home NDC 54482-144 CARNITOR
Product NDC 54482-144
11-digit product format 544820144
Labeler code 54482
Product ID 54482-144_24e9abdb-6e9d-4f27-9e0f-8e8a3a462615
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levocarnitine
Dosage form TABLET
Route ORAL
Labeler Leadiant Biosciences, Inc.
Application NDA018948
Marketing category NDA
Marketing start 1985-12-27
Substance LEVOCARNITINE
Active strength 330 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018948-001 CARNITOR LEVOCARNITINE 330MG TABLET / ORAL AB RLD, RS 1985-12-27 N018948-002 CARNITOR LEVOCARNITINE 1GM/10ML SOLUTION / ORAL 1988-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018948-001 AB
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 3 · 84 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 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CARNITOR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCARNITINE 330 mg/1
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 197448 Internal RxNorm lookup 206346 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 54482-144-07 CARNITOR 9 in 1 BLISTER PACK TABLET 9 21 54482-144-07 CARNITOR 10 in 1 CARTON TABLET 10 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54482-144 CARNITOR (LEVOCARNITINE) TABLET [LEADIANT BIOSCIENCES, INC.] 21 Current NDC, Legacy NDC, 2 package rows 20241114_d2133bc3-9c15-48bd-8b16-b8995a6a14cd.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 54482-144-07 54482014407 10 BLISTER PACK in 1 CARTON (54482-144-07) / 9 TABLET in 1 BLISTER PACK 10 blister pack 1985-12-27 0000-00-00 No No Current