Home NDC 42043-191 Levetiracetam
Product NDC 42043-191
11-digit product format 420430191
Labeler code 42043
Product ID 42043-191_7967f8f4-eba8-4849-a176-944fffa2ee53
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Karalex Pharma LLC
Application ANDA078526
Marketing category ANDA
Marketing start 2011-09-01
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 E
Listing certified through 2017-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078526-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 A078526-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 A078526-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078526-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078526-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078526-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings#