Home NDC 50383-172-90 Levocarnitine
Product NDC 50383-172
Requested package NDC 50383-172-90
11-digit product format 503830172
Labeler code 50383
Product ID 50383-172_fab8a875-841f-496d-ba11-02593522599b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levocarnitine
Dosage form TABLET
Route ORAL
Labeler Akorn
Application NDA018948
Marketing category NDA
Marketing start 2005-11-01
Marketing end 0000-00-00
Substance LEVOCARNITINE
Active strength 330 mg/1
Pharmacologic classes Carnitine Analog [EPC], Carnitine [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50383-172-90 Levocarnitine 10 in 1 BLISTER PACK TABLET 10 6 50383-172-90 Levocarnitine 9 in 1 CARTON TABLET 9 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-172 LEVOCARNITINE TABLET [AKORN] 6 Legacy NDC, 2 package rows 20221111_c8a590a7-628b-45c5-ac2c-24214a69eaa6.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CARNITOR LEVOCARNITINE Leadiant Biosciences, Inc. d2133bc3-9c15-48bd-8b16-b8995a6a14cd 2024-10-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 018948 application number: NDA018948
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 50383-172-90 50383017290 9 BLISTER PACK in 1 CARTON (50383-172-90) > 10 TABLET in 1 BLISTER PACK 9 blister pack 2005-11-01 0000-00-00 No No Current