Home NDC 55289-097-30 Keppra
Product NDC 55289-097
Requested package NDC 55289-097-30
11-digit product format 552890097
Labeler code 55289
Product ID 55289-097_d91c69b8-b486-3f88-e053-2a95a90ac711
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, 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 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded levetiracetam ACTIVE INGREDIENT 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 levetiracetam ACTIVE MOIETY 44YRR34555 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 polyethylene glycol 6000 INACTIVE INGREDIENT 30IQX730WE KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 talc INACTIVE INGREDIENT 7SEV7J4R1U KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-097-30 55289009730 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-097-30) 2009-10-05 0000-00-00 No No Current