Levetiracetam

Product NDC: 44567-501
Requested package NDC: 44567-501-90
11-digit product format: 445670501
Labeler code: 44567
Product ID: 44567-501_5d75a4ee-4a82-48d9-809b-eabea28c6e96
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: WG Critical Care, LLC
Application: NDA202543
Marketing category: NDA
Marketing start: 2020-08-24
Substance: LEVETIRACETAM
Active strength: 5 mg/mL
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09
N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09
N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09
N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N202543-001	AP
N202543-002	AP
N202543-003	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 4 · 158 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	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N202543-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202543-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202543-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202543-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202543-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202543-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202543-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202543-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202543-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202543-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202543-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202543-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202543-001	AP	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
44YRR34555	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1193358	Internal RxNorm lookup
1193360	Internal RxNorm lookup
1193362	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
62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
76e81f18-c6b9-f226-530a-a6296d5cd5f4	Product name	6	20251106
087c9486-f4a9-a565-c6fb-d6fa49f4572a	Product name	6	20230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
ce453ca5-90cf-41ed-9de4-de519f70a0f2	Product name	2	20160303
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
66666eb8-1fa6-4a60-bae9-e564e73b4cd5	Product name	1	20150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477	Product name	1	20150410
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
44567-501-01	Levetiracetam	100 mL in 1 BAG	INJECTION	100	6
44567-501-10	Levetiracetam	10 in 1 CARTON	INJECTION	10	6
44567-501-02	Levetiracetam	100 mL in 1 BAG	INJECTION	100	3
44567-501-90	Levetiracetam	10 in 1 CARTON	INJECTION	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44567-501-01	ML - Milliliter	44567-501	9e2d0692-78d1-449a-9b18-1555c0c12a1b	1	2022-07-06
44567-501-02	ML - Milliliter	44567-501	99ebf4bb-00a7-4827-b7a9-becb303cd0f8	1	2023-06-06
44567-501-10	ML - Milliliter	44567-501	cff2ee94-7849-4182-85fb-4dd98195753d	1	2022-06-06
44567-501-90	ML - Milliliter	44567-501	080c3ef7-7acd-460a-a666-737f289d63c7	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44567-501	LEVETIRACETAM INJECTION [WG CRITICAL CARE, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240601_62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926.zip
44567-501	LEVETIRACETAM INJECTION [WG CRITICAL CARE, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20240113_5e5b0ed3-b104-45a7-bb3e-ee56febb46e8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	WG Critical Care, LLC	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	2024-03-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202543 application number: NDA202543 ndc (product): 44567-501
Levetiracetam	LEVETIRACETAM	Mylan Institutional LLC	70e52e89-3844-4cd9-a406-b29e9520a12c	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202543 application number: NDA202543
Levetiracetam	LEVETIRACETAM	WG Critical Care, LLC	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202543 application number: NDA202543 ndc (package): 44567-501-90 ndc (product): 44567-501 ndc11 (package): 44567050190

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44YRR34555	LEVETIRACETAM	102767-28-2	LEVETIRACETAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1193358	levETIRAcetam 1000 MG in 100 ML Injection	PSN	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193360	levETIRAcetam 1500 MG in 100 ML Injection	PSN	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193362	levETIRAcetam 500 MG in 100 ML Injection	PSN	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193358	100 ML levetiracetam 10 MG/ML Injection	SCD	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193360	100 ML levetiracetam 15 MG/ML Injection	SCD	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193362	100 ML levetiracetam 5 MG/ML Injection	SCD	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193358	levetiracetam 1000 MG per 100 ML Injection	SY	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193360	levetiracetam 1500 MG per 100 ML Injection	SY	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193362	levetiracetam 500 MG per 100 ML Injection	SY	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	6
1193358	levETIRAcetam 1000 MG in 100 ML Injection	PSN	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	3
1193362	levETIRAcetam 500 MG in 100 ML Injection	PSN	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	3
1193358	100 ML levetiracetam 10 MG/ML Injection	SCD	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	3
1193362	100 ML levetiracetam 5 MG/ML Injection	SCD	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	3
1193358	levetiracetam 1000 MG per 100 ML Injection	SY	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	3
1193362	levetiracetam 500 MG per 100 ML Injection	SY	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44567-501-90	44567050190	10 BAG in 1 CARTON (44567-501-90) / 100 mL in 1 BAG (44567-501-02)	10 bag	2022-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levetiracetam	WG Critical Care, LLC	2024-03-29	HUMAN PRESCRIPTION DRUG LABEL	6
Levetiracetam	WG Critical Care, LLC	2023-10-30	HUMAN PRESCRIPTION DRUG LABEL	3