Levocarnitine

Product NDC: 50383-172
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50383-172		I	Inactivated by FDA		2026-08-17
excluded package	package	50383-172	50383-172-90	I	Inactivated by FDA		2026-08-17

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-172-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-172-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-172-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-172-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-172-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-172-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-172-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-172-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-172-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-172-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-172-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-172-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-172-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-172-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-172-90	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	N018948-001	CARNITOR	330MG	TABLET / ORAL	AB	RLD, RS	1985-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018948-002	CARNITOR	1GM/10ML	SOLUTION / ORAL			1988-04-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N018948-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018948-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018948-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018948-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018948-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018948-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018948-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018948-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018948-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018948-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018948-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018948-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018948-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018948-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018948-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018948-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018948-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018948-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018948-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018948-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018948-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018948-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018948-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018948-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018948-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018948-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018948-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018948-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018948-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018948-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018948-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018948-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018948-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018948-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018948-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018948-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018948-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018948-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018948-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018948-001	AB	1	`e64feba35796…`

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
50383-172-90	2024-01-30	C162847	48780-1	d6a99b39-e3d8-a426-e053-dadaa90af4c2	Levocarnitine Tablets USP (330 mg)
50383-172-90	2022-02-01	C162847	48780-1	d6a99b39-e3d8-a426-e053-dadaa90af4c2	Levocarnitine Tablets USP (330 mg)
50383-172-90	2022-01-28	C162847	48780-1	d6a99b39-e3d8-a426-e053-dadaa90af4c2	Levocarnitine Tablets USP (330 mg)

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-172-90	EA - Each	50383-172	d42a6c2a-f4d8-4a65-ad9c-f536b075f321	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOCARNITINE	ACTIVE INGREDIENT	0G389FZZ9M	LEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]	1
LEVOCARNITINE	ACTIVE MOIETY	0G389FZZ9M	LEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVOCARNITINE TABLET [HI-TECH PHARMACAL CO., INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-172	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

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
197448	levOCARNitine 330 MG Oral Tablet	PSN	c8a590a7-628b-45c5-ac2c-24214a69eaa6	6
197448	levocarnitine 330 MG Oral Tablet	SCD	c8a590a7-628b-45c5-ac2c-24214a69eaa6	6

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocarnitine Tablets USP (330 mg)	Akorn \| Akorn Operating Company LLC \| Alfasigma, S.p.A	2022-11-10	HUMAN PRESCRIPTION DRUG LABEL	6