Carnitor SF

Product NDC: 54482-148
11-digit product format: 544820148
Labeler code: 54482
Product ID: 54482-148_88041d93-8f95-4551-bba1-df964b092504
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 1.

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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	N019257-001	CARNITOR	1GM/10ML	SOLUTION / ORAL	AA	RLD, RS	1986-04-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019257-002	CARNITOR SF	1GM/10ML	SOLUTION / ORAL	AA	RLD	2007-03-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	N019257-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019257-002	AA	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 54482-148
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

Additional Listing Data#

Finished product: Yes
Brand name base: Carnitor SF
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
dd904490-83f3-4cd3-bb6f-68e28509b4b6	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
54482-148-01	Carnitor SF	24 in 1 CASE	SOLUTION	24	23
54482-148-01	Carnitor SF	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118	23
54482-148-02	Carnitor SF	24 in 1 CASE	SOLUTION	24	23
54482-148-02	Carnitor SF	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54482-148-01	ML - Milliliter	54482-148	cdbca2de-5471-4def-a460-11dd8654cc92	1	2012-07-24
54482-148-02	ML - Milliliter	54482-148	5bf22d81-9cdf-4dcb-987b-2ecb216b3d9b	1	2025-07-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOCARNITINE	ACTIVE INGREDIENT	0G389FZZ9M	CARNITOR SF (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
LEVOCARNITINE	ACTIVE MOIETY	0G389FZZ9M	CARNITOR SF (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	CARNITOR SF (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CARNITOR SF (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CARNITOR SF (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CARNITOR SF (LEVOCARNITINE) SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	CARNITOR SF (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
54482-148	CARNITOR SF (LEVOCARNITINE) SOLUTION [LEADIANT BIOSCIENCES, INC.]	23	Current NDC, Legacy NDC, 4 package rows	20241114_dd904490-83f3-4cd3-bb6f-68e28509b4b6.zip

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	dd904490-83f3-4cd3-bb6f-68e28509b4b6	23
315134	levOCARNitine 1 GM in 10 mL Oral Solution	PSN	dd904490-83f3-4cd3-bb6f-68e28509b4b6	23
206343	levocarnitine 100 MG/ML Oral Solution [Carnitor]	SBD	dd904490-83f3-4cd3-bb6f-68e28509b4b6	23
315134	levocarnitine 100 MG/ML Oral Solution	SCD	dd904490-83f3-4cd3-bb6f-68e28509b4b6	23
206343	Carnitor 1 GM per 10 ML Oral Solution	SY	dd904490-83f3-4cd3-bb6f-68e28509b4b6	23
206343	Carnitor 100 MG/ML Oral Solution	SY	dd904490-83f3-4cd3-bb6f-68e28509b4b6	23
315134	levocarnitine 1 GM per 10 ML Oral Solution	SY	dd904490-83f3-4cd3-bb6f-68e28509b4b6	23
315134	levocarnitine 10 % Oral Solution	SY	dd904490-83f3-4cd3-bb6f-68e28509b4b6	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54482-148-01	54482014801	24 BOTTLE, PLASTIC in 1 CASE (54482-148-01) / 118 mL in 1 BOTTLE, PLASTIC	1986-04-10	0000-00-00	No	No	Current
54482-148-02	54482014802	24 BOTTLE, PLASTIC in 1 CASE (54482-148-02) / 118 mL in 1 BOTTLE, PLASTIC	2024-09-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution (1 g per 10 mL multidose)	Leadiant Biosciences, Inc.	2024-11-04	HUMAN PRESCRIPTION DRUG LABEL	23