Home NDC 63629-7516 Levetiracetam
Product NDC 63629-7516
11-digit product format 636297516
Labeler code 63629
Product ID 63629-7516_d310428a-bf9e-4838-b409-3282dde4890b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078106
Marketing category ANDA
Marketing start 2012-09-11
Substance LEVETIRACETAM
Active strength 1000 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A078106-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 A078106-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 A078106-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 A078106-004 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 168 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 2026-08-18 06:07:40 2026-07 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Levetiracetam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 44YRR34555 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 387003 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-7516-1 2024-05-16 These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 63629-7516-2 2024-05-16 These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 63629-7516-3 2024-05-16 These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 63629-7516-4 2024-05-16 These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 63629-7516-1 2024-01-30 These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 63629-7516-2 2024-01-30 These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 63629-7516-3 2024-01-30 These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 63629-7516-4 2024-01-30 These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-7516-1 Levetiracetam 30 in 1 BOTTLE TABLET, FILM COATED 30 5 63629-7516-2 Levetiracetam 90 in 1 BOTTLE TABLET, FILM COATED 90 5 63629-7516-3 Levetiracetam 58 in 1 BOTTLE TABLET, FILM COATED 58 5 63629-7516-4 Levetiracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-7516 LEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK] 5 Current NDC, Legacy NDC, 4 package rows 20240518_ed8e88d0-993e-4683-bdcf-31578130d3df.zip
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-7516-1 63629751601 30 TABLET, FILM COATED in 1 BOTTLE (63629-7516-1) 2024-04-03 0000-00-00 No No Current 63629-7516-2 63629751602 90 TABLET, FILM COATED in 1 BOTTLE (63629-7516-2) 2018-01-23 0000-00-00 No No Current 63629-7516-3 63629751603 58 TABLET, FILM COATED in 1 BOTTLE (63629-7516-3) 2024-04-03 0000-00-00 No No Current 63629-7516-4 63629751604 60 TABLET, FILM COATED in 1 BOTTLE (63629-7516-4) 2024-04-03 0000-00-00 No No Current