Levetiracetam

Product NDC: 63629-4137
11-digit product format: 636294137
Labeler code: 63629
Product ID: 63629-4137_505a2d97-ea8d-4e3a-9af7-95df7f59d89b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078154
Marketing category: ANDA
Marketing start: 2009-01-15
Substance: LEVETIRACETAM
Active strength: 500 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 6 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	63629-4137-3
excluded package	package	63629-4137-4
excluded package	package	63629-4137-2
excluded package	package	63629-4137-1
excluded package	package	63629-4137-5

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078154-001	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15
A078154-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15
A078154-003	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078154-001	AB
A078154-002	AB
A078154-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-002	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-003	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2009-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078154-001	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2009-01-15	`8072bd15b7f6…`

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	A078154-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078154-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078154-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078154-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078154-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078154-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078154-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078154-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078154-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078154-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078154-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078154-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078154-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078154-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078154-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078154-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078154-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levetiracetam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVETIRACETAM	500 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311289	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
24f815ef-58e6-42b9-8137-adcd6c382aa6	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
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2	Product name	2	20160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5	Product name	1	20150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477	Product name	1	20150410

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4137-1	2020-07-21	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-2	2020-07-21	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-3	2020-07-21	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-4	2020-07-21	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-5	2020-07-21	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-1	2020-01-31	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-2	2020-01-31	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-3	2020-01-31	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-4	2020-01-31	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999
63629-4137-5	2020-01-31	These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP. LEVETIRACETAM tablets USP, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-4137-1	Levetiracetam	90 in 1 BOTTLE	TABLET, FILM COATED	90	18
63629-4137-2	Levetiracetam	60 in 1 BOTTLE	TABLET, FILM COATED	60	18
63629-4137-3	Levetiracetam	30 in 1 BOTTLE	TABLET, FILM COATED	30	18
63629-4137-4	Levetiracetam	120 in 1 BOTTLE	TABLET, FILM COATED	120	18
63629-4137-5	Levetiracetam	28 in 1 BOTTLE	TABLET, FILM COATED	28	18
63629-4137-6	Levetiracetam	100 in 1 BOTTLE	TABLET, FILM COATED	100	18
63629-4137-7	Levetiracetam	21 in 1 BOTTLE	TABLET, FILM COATED	21	18
63629-4137-8	Levetiracetam	180 in 1 BOTTLE	TABLET, FILM COATED	180	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4137-1	EA - Each	63629-4137	3a3ef8b3-2bb0-45be-b3f7-06f006fb9c64	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-4137	LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	17	Current NDC, Legacy NDC, 8 package rows	20240607_24f815ef-58e6-42b9-8137-adcd6c382aa6.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	a1b28234-1f7c-40bf-80a7-6cc98b3839fe	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	REMEDYREPACK INC.	1c26c0ad-9d37-45c5-9091-849509f4fc01	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	90e01877-abcb-4697-a7ed-9afe5ee77050	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	PD-Rx Pharmaceuticals, Inc.	c4b2da6a-ed50-4a54-90bd-32f76b178736	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Lupin Pharmaceuticals, Inc.	df661166-325d-4071-9bc1-f7bf992996d2	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	24f815ef-58e6-42b9-8137-adcd6c382aa6	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154 ndc (product): 63629-4137
Levetiracetam	LEVETIRACETAM	Bryant Ranch Prepack	9e3171c9-70e2-4725-8aca-c7f83773940d	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Preferred Pharmaceuticals, Inc.	e31c6830-4647-4481-b4f1-494a52c48b1b	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154
Levetiracetam	LEVETIRACETAM	Proficient Rx LP	6bdbc193-d86b-4bd5-8e88-4ea964d2cdde	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078154 application number: ANDA078154

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
311289	levETIRAcetam 500 MG Oral Tablet	PSN	24f815ef-58e6-42b9-8137-adcd6c382aa6	18
311289	levetiracetam 500 MG Oral Tablet	SCD	24f815ef-58e6-42b9-8137-adcd6c382aa6	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4137-1	63629413701	90 TABLET, FILM COATED in 1 BOTTLE (63629-4137-1)	2010-02-18	0000-00-00	No	No	Current
63629-4137-2	63629413702	60 TABLET, FILM COATED in 1 BOTTLE (63629-4137-2)	2011-09-06	0000-00-00	No	No	Current
63629-4137-3	63629413703	30 TABLET, FILM COATED in 1 BOTTLE (63629-4137-3)	2012-02-24	0000-00-00	No	No	Current
63629-4137-4	63629413704	120 TABLET, FILM COATED in 1 BOTTLE (63629-4137-4)	2013-04-19	0000-00-00	No	No	Current
63629-4137-5	63629413705	28 TABLET, FILM COATED in 1 BOTTLE (63629-4137-5)	2023-03-06	0000-00-00	No	No	Current
63629-4137-6	63629413706	100 TABLET, FILM COATED in 1 BOTTLE (63629-4137-6)	2023-03-06		No	No	Current
63629-4137-7	63629413707	21 TABLET, FILM COATED in 1 BOTTLE (63629-4137-7)	2024-04-02		No	No	Current
63629-4137-8	63629413708	180 TABLET, FILM COATED in 1 BOTTLE (63629-4137-8)	2026-04-02		No	No	Current