Home NDC 65084-458 Keppra
Product NDC 65084-458
11-digit product format 650840458
Labeler code 65084
Product ID 65084-458_ef7f5ccc-c93b-47b3-a915-3e76610073a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mckesson Rxpak Inc
Application NDA021035
Marketing category NDA
Marketing start 2000-04-24
Marketing end 0000-00-00
Substance LEVETIRACETAM
Active strength 500 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product Y Unknown FDA exclusion code: Y e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 65084-458-36 Y Unknown FDA exclusion code: Y e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65084-458-36 E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…
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 N021035-001 KEPPRA LEVETIRACETAM 250MG TABLET / ORAL AB RLD 1999-11-30 N021035-002 KEPPRA LEVETIRACETAM 500MG TABLET / ORAL AB RLD 1999-11-30 N021035-003 KEPPRA LEVETIRACETAM 750MG TABLET / ORAL AB RLD 1999-11-30 N021035-004 KEPPRA LEVETIRACETAM 1GM TABLET / ORAL AB RLD, RS 2006-01-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021035-001 8802142 2031-06-07 Drug product 2014-09-10 N021035-001 8802142*PED 2031-12-07 Pediatric extension N021035-002 8802142 2031-06-07 Drug product 2014-09-10 N021035-002 8802142*PED 2031-12-07 Pediatric extension N021035-003 8802142 2031-06-07 Drug product 2014-09-10 N021035-003 8802142*PED 2031-12-07 Pediatric extension N021035-004 8802142 2031-06-07 Drug product 2014-09-10 N021035-004 8802142*PED 2031-12-07 Pediatric extension
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 5 · 164 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 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Observed Orange Book patent history# Patent history page 1 of 9 · 328 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021035-001 8802142 2031-06-07 Drug product 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-001 8802142*PED 2031-12-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-002 8802142 2031-06-07 Drug product 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-002 8802142*PED 2031-12-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-003 8802142 2031-06-07 Drug product 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-003 8802142*PED 2031-12-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-004 8802142 2031-06-07 Drug product 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021035-004 8802142*PED 2031-12-07 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-001 8802142 2031-06-07 Drug product 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-001 8802142*PED 2031-12-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-002 8802142 2031-06-07 Drug product 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-002 8802142*PED 2031-12-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-003 8802142 2031-06-07 Drug product 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-003 8802142*PED 2031-12-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-004 8802142 2031-06-07 Drug product 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021035-004 8802142*PED 2031-12-07 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021035-001 8802142 2031-06-07 Drug product 2014-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-001 8802142*PED 2031-12-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-002 8802142 2031-06-07 Drug product 2014-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-002 8802142*PED 2031-12-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-003 8802142 2031-06-07 Drug product 2014-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-003 8802142*PED 2031-12-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-004 8802142 2031-06-07 Drug product 2014-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021035-004 8802142*PED 2031-12-07 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-001 8802142 2031-06-07 Drug product 2014-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-001 8802142*PED 2031-12-07 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-002 8802142 2031-06-07 Drug product 2014-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-002 8802142*PED 2031-12-07 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-003 8802142 2031-06-07 Drug product 2014-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-003 8802142*PED 2031-12-07 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-004 8802142 2031-06-07 Drug product 2014-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021035-004 8802142*PED 2031-12-07 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-001 8802142 2031-06-07 Drug product 2014-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-001 8802142*PED 2031-12-07 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-002 8802142 2031-06-07 Drug product 2014-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-002 8802142*PED 2031-12-07 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-003 8802142 2031-06-07 Drug product 2014-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-003 8802142*PED 2031-12-07 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-004 8802142 2031-06-07 Drug product 2014-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021035-004 8802142*PED 2031-12-07 Pediatric extension b8a1b40f171c…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded levetiracetam ACTIVE INGREDIENT 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 levetiracetam ACTIVE MOIETY 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 aluminum oxide INACTIVE INGREDIENT LMI26O6933 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 polyethylene glycol 6000 INACTIVE INGREDIENT 30IQX730WE KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [RXPAK DIVISION OF MCKESSON CORPORATION] 1
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 Keppra LEVETIRACETAM UCB, Inc. 3ca9df05-a506-4ec8-a4fe-320f1219ab21 2026-01-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 021035 application number: NDA021035