Levocarnitine

Product NDC: 50383-171
Requested package NDC: 50383-171-04
11-digit product format: 503830171
Labeler code: 50383
Product ID: 50383-171_60d74bef-d602-4750-90ea-5b0eab02555e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levocarnitine
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: NDA019257
Marketing category: NDA
Marketing start: 1986-04-10
Marketing end: 0000-00-00
Substance: LEVOCARNITINE
Active strength: 1 g/10mL
Pharmacologic classes: Carnitine Analog [EPC], Carnitine [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50383-171	50383-171-04	I	Inactivated by FDA		2026-10-05

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
N019257-001	CARNITOR	LEVOCARNITINE	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10
N019257-002	CARNITOR SF	LEVOCARNITINE	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N019257-001	AA
N019257-002	AA

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	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019257-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019257-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019257-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019257-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019257-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019257-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019257-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019257-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019257-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019257-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019257-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019257-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019257-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019257-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019257-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019257-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019257-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019257-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019257-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019257-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019257-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019257-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019257-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019257-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019257-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019257-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019257-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019257-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019257-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019257-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019257-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019257-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019257-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019257-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019257-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019257-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019257-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019257-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019257-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019257-002	AA	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
08c722ec-780f-bb7b-8f14-3d4f7bf0e098	Product name	2	20240205
e2f276e5-439f-b432-b5e5-b0cfa993da69	Product name	3	20220609
4585a4fb-0028-3d95-020c-9b1c40bf15e0	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-171-04	2024-01-30	C162847	48780-1	1030e365-1f8b-111a-e063-dadaa90a10e2	Levocarnitine Oral Solution, USP (1 g per 10 mL multidose)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50383-171-04	Levocarnitine	118 mL in 1 BOTTLE	SOLUTION	118		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-171-04	ML - Milliliter	50383-171	6da1f574-347c-4f48-8fde-64384dd99e80	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOCARNITINE	ACTIVE INGREDIENT	0G389FZZ9M	LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]	1
LEVOCARNITINE	ACTIVE MOIETY	0G389FZZ9M	LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]	1
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]	1
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVOCARNITINE SOLUTION [HI-TECH PHARMACAL CO., INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-171	LEVOCARNITINE SOLUTION [AKORN]	8	Legacy NDC, 1 package rows	20221116_3563c2f5-9814-4d55-8d90-bd7d6dcff36b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carnitor SF	LEVOCARNITINE	Leadiant Biosciences, Inc.	dd904490-83f3-4cd3-bb6f-68e28509b4b6	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019257 application number: NDA019257
Carnitor	LEVOCARNITINE	Leadiant Biosciences, Inc.	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	2024-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019257 application number: NDA019257

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0G389FZZ9M	LEVOCARNITINE	541-15-1	LEVOCARNITINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
315134	levOCARNitine 1 GM in 10 mL Oral Solution	PSN	3563c2f5-9814-4d55-8d90-bd7d6dcff36b	8
315134	levocarnitine 100 MG/ML Oral Solution	SCD	3563c2f5-9814-4d55-8d90-bd7d6dcff36b	8
315134	levocarnitine 1 GM per 10 ML Oral Solution	SY	3563c2f5-9814-4d55-8d90-bd7d6dcff36b	8
315134	levocarnitine 10 % Oral Solution	SY	3563c2f5-9814-4d55-8d90-bd7d6dcff36b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-171-04	50383017104	118 mL in 1 BOTTLE (50383-171-04)	118 ml	2007-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocarnitine Oral Solution, USP (1 g per 10 mL multidose)	Akorn \| Akorn Operating Company LLC	2022-11-15	HUMAN PRESCRIPTION DRUG LABEL	8