Home NDC 0378-5619 Levetiracetam
Product NDC 0378-5619
11-digit product format 003785619
Labeler code 0378
Product ID 0378-5619_8eaa3318-fe96-4d3e-9f49-3286cb04bfbf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA090261
Marketing category ANDA
Marketing start 2009-12-10
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090261-001 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090261-001 AB
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 2 · 41 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 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090261-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-12-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311289 Internal RxNorm lookup 311290 Internal RxNorm lookup 387003 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-5619-91 Levetiracetam 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 41
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 POVIDONES INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-5619 LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 38 Current NDC, Legacy NDC, 1 package rows 20241011_0a987d59-560f-4650-96ec-31aec81953b5.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 · 1 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 0378-5619-91 00378561991 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5619-91) 2009-12-10 0000-00-00 No No Current