Home Applications 021035 Application 021035
Type NDA
Sponsor UCB INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KEPPRA LEVETIRACETAM TABLET;ORAL 250MG Yes No 002 KEPPRA LEVETIRACETAM TABLET;ORAL 500MG Yes No 003 KEPPRA LEVETIRACETAM TABLET;ORAL 750MG Yes No 004 KEPPRA LEVETIRACETAM TABLET;ORAL 1GM Yes 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 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…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 26 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-070 Keppra levetiracetam Rebel Distributors Corp NDA Current 50474-594 Keppra levetiracetam UCB, Inc. NDA Current 50474-594 Keppra levetiracetam UCB, Inc. NDA Current 50474-594 Keppra levetiracetam UCB, Inc. NDA Current 50474-594 Keppra levetiracetam UCB, Inc. NDA Current 50474-595 Keppra levetiracetam UCB, Inc. NDA Current 50474-595 Keppra levetiracetam UCB, Inc. NDA Current 50474-595 Keppra levetiracetam UCB, Inc. NDA Current 50474-595 Keppra levetiracetam UCB, Inc. NDA Current 50474-596 Keppra levetiracetam UCB, Inc. NDA Current 50474-596 Keppra levetiracetam UCB, Inc. NDA Current 50474-596 Keppra levetiracetam UCB, Inc. NDA Current 50474-596 Keppra levetiracetam UCB, Inc. NDA Current 50474-597 Keppra levetiracetam UCB, Inc. NDA Current 50474-597 Keppra levetiracetam UCB, Inc. NDA Current 50474-597 Keppra levetiracetam UCB, Inc. NDA Current 50474-597 Keppra levetiracetam UCB, Inc. NDA Current 55289-097 Keppra levetiracetam PD-Rx Pharmaceuticals, Inc. NDA Current 55289-097 Keppra levetiracetam PD-Rx Pharmaceuticals, Inc. NDA Current 55289-097 Keppra levetiracetam PD-Rx Pharmaceuticals, Inc. NDA Current 55289-097 Keppra levetiracetam PD-Rx Pharmaceuticals, Inc. NDA Current 55289-097 Keppra levetiracetam PD-Rx Pharmaceuticals, Inc. NDA Current 55289-097 Keppra levetiracetam PD-Rx Pharmaceuticals, Inc. NDA Current 65084-457 Keppra levetiracetam Mckesson Rxpak Inc NDA Current 65084-458 Keppra levetiracetam Mckesson Rxpak Inc NDA Current 65084-459 Keppra levetiracetam Mckesson Rxpak Inc NDA Current