Carnitor

Product NDC: 54482-145
11-digit product format: 544820145
Labeler code: 54482
Product ID: 54482-145_c1636127-9b6a-4443-81d9-e2607ae46e33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levocarnitine
Dosage form: SOLUTION
Route: ORAL
Labeler: Leadiant Biosciences, Inc.
Application: NDA019257
Marketing category: NDA
Marketing start: 1986-04-10
Substance: LEVOCARNITINE
Active strength: 1 g/10mL
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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N019257-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019257-002	AA	1	`bb7c543d1eb4…`

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/10mL

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
206343	Internal RxNorm lookup
315134	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54482-145-08	Carnitor	24 in 1 CASE	SOLUTION	24	23
54482-145-08	Carnitor	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118	23
54482-145-09	Carnitor	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118	23
54482-145-09	Carnitor	24 in 1 CASE	SOLUTION	24	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54482-145-08	ML - Milliliter	54482-145	92b6dfb7-ffa4-4298-a2fb-2c1dab9ae1ad	1	2012-07-24
54482-145-09	ML - Milliliter	54482-145	df78f355-8875-4cf9-a62d-27a68d5fb569	1	2024-09-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOCARNITINE	ACTIVE INGREDIENT	0G389FZZ9M	CARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
LEVOCARNITINE	ACTIVE MOIETY	0G389FZZ9M	CARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	CARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	CARNITOR (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54482-145	CARNITOR (LEVOCARNITINE) SOLUTION [LEADIANT BIOSCIENCES, INC.]	23	Current NDC, Legacy NDC, 4 package rows	20240504_b2cbc620-59fd-47b6-9e4b-7e3e31533a1c.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 ndc (product): 54482-145

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
206343	Carnitor 1 GM in 10 mL Oral Solution	PSN	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	23
315134	levOCARNitine 1 GM in 10 mL Oral Solution	PSN	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	23
206343	levocarnitine 100 MG/ML Oral Solution [Carnitor]	SBD	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	23
315134	levocarnitine 100 MG/ML Oral Solution	SCD	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	23
206343	Carnitor 1 GM per 10 ML Oral Solution	SY	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	23
206343	Carnitor 100 MG/ML Oral Solution	SY	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	23
315134	levocarnitine 1 GM per 10 ML Oral Solution	SY	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	23
315134	levocarnitine 10 % Oral Solution	SY	b2cbc620-59fd-47b6-9e4b-7e3e31533a1c	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54482-145-08	54482014508	24 BOTTLE, PLASTIC in 1 CASE (54482-145-08) / 118 mL in 1 BOTTLE, PLASTIC	1986-04-10	0000-00-00	No	No	Current
54482-145-09	54482014509	24 BOTTLE, PLASTIC in 1 CASE (54482-145-09) / 118 mL in 1 BOTTLE, PLASTIC	2024-03-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARNITOR ® (levocarnitine) Oral Solution (1 g per 10 mL multidose)	Leadiant Biosciences, Inc.	2024-01-23	HUMAN PRESCRIPTION DRUG LABEL	23