Home DailyMed 4b8958d2-38fc-41b7-ba4c-1abf729b3f61 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:41:40 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 176 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 2026-10-15 13:18:30 2026-09 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021035-001 KEPPRA 250MG TABLET / ORAL AB RLD 1999-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-002 KEPPRA 500MG TABLET / ORAL AB RLD 1999-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-003 KEPPRA 750MG TABLET / ORAL AB RLD 1999-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-004 KEPPRA 1GM TABLET / ORAL AB RLD, RS 2006-01-06 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
Observed Orange Book patent history# Patent history page 1 of 9 · 352 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N021035-001 8802142 2031-06-07 Drug product 2014-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-001 8802142*PED 2031-12-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-002 8802142 2031-06-07 Drug product 2014-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-002 8802142*PED 2031-12-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-003 8802142 2031-06-07 Drug product 2014-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-003 8802142*PED 2031-12-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-004 8802142 2031-06-07 Drug product 2014-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021035-004 8802142*PED 2031-12-07 Pediatric extension c2088c7a36db…2026-09-14 22:38:34 2026-08 N021035-001 8802142 2031-06-07 Drug product 2014-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-001 8802142*PED 2031-12-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-002 8802142 2031-06-07 Drug product 2014-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-002 8802142*PED 2031-12-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-003 8802142 2031-06-07 Drug product 2014-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-003 8802142*PED 2031-12-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-004 8802142 2031-06-07 Drug product 2014-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021035-004 8802142*PED 2031-12-07 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021035-001 8802142 2031-06-07 Drug product 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-001 8802142*PED 2031-12-07 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-002 8802142 2031-06-07 Drug product 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-002 8802142*PED 2031-12-07 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-003 8802142 2031-06-07 Drug product 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-003 8802142*PED 2031-12-07 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-004 8802142 2031-06-07 Drug product 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021035-004 8802142*PED 2031-12-07 Pediatric extension caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.