Home NDC 0517-1075 Levocarnitine
Product NDC 0517-1075
11-digit product format 005171075
Labeler code 0517
Product ID 0517-1075_114eaeda-8965-4c92-a3ff-15021b305464
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levocarnitine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Application ANDA075861
Marketing category ANDA
Marketing start 2023-06-21
Substance LEVOCARNITINE
Active strength 200 mg/mL
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 A075861-001 LEVOCARNITINE LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075861-001 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 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075861-001 LEVOCARNITINE 200MG/ML INJECTABLE / INJECTION AP 2001-06-22 e64feba35796…
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 Levocarnitine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCARNITINE 200 mg/mL
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 1791371 Internal RxNorm lookup 2673428 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 0517-1075-01 Levocarnitine 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 11 0517-1075-01 Levocarnitine 1 in 1 CARTON INJECTION, SOLUTION 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOCARNITINE ACTIVE INGREDIENT 0G389FZZ9M LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 4 LEVOCARNITINE ACTIVE MOIETY 0G389FZZ9M LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-1075 LEVOCARNITINE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 11 Current NDC, 2 package rows 20240123_cc4da2c3-f939-444d-9b5b-a57b6051c190.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 Marketing start Sample Exclude flag Status 0517-1075-01 00517107501 1 VIAL, SINGLE-DOSE in 1 CARTON (0517-1075-01) / 20 mL in 1 VIAL, SINGLE-DOSE 2023-06-21 No No Current