FDA.reportPublic FDA data

28877-5960-0

Product NDC
28877-5960
Requested package NDC
28877-5960-0
11-digit product format
288775960
Labeler code
28877
Product ID
28877-5960_8940529e-980f-4f1a-9746-9e8d64661752
Type
DRUG FOR FURTHER PROCESSING
Nonproprietary name
levetiracetam
Dosage form
TABLET, FILM COATED
Marketing category
DRUG FOR FURTHER PROCESSING
Marketing start
2000-04-24
Substance
LEVETIRACETAM
Active strength
750 mg/1
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage28877-596028877-5960-0UNFINISHEDActive or certified unfinished drug listing2026-09-08

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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM750 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levetiracetamACTIVE INGREDIENT44YRR34555KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
levetiracetamACTIVE MOIETY44YRR34555KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A8KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PKEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEKEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4KEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UKEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPKEPPRA (LEVETIRACETAM) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261336Keppra 500 MG Oral TabletPSNd1329893-a8bc-4f31-a31b-76690d1110351
311289levETIRAcetam 500 MG Oral TabletPSNd1329893-a8bc-4f31-a31b-76690d1110351
261336levetiracetam 500 MG Oral Tablet [Keppra]SBDd1329893-a8bc-4f31-a31b-76690d1110351
311289levetiracetam 500 MG Oral TabletSCDd1329893-a8bc-4f31-a31b-76690d1110351
261336Keppra 500 MG Oral TabletSYd1329893-a8bc-4f31-a31b-76690d1110351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
28877-5960-028877596000175000 TABLET, FILM COATED in 1 DRUM (28877-5960-0)24-APR-00Current