Home NDC 55111-248 Levetiracetam
Product NDC 55111-248
11-digit product format 551110248
Labeler code 55111
Product ID 55111-248_1b3acece-e7d3-2b1f-db18-77e04f6d7918
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA078904
Marketing category ANDA
Marketing start 2009-01-15
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 A078904-001 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078904-001 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 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078904-001 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 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 · 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55111-248-01 Levetiracetam 100 in 1 BOTTLE TABLET 100 7 55111-248-05 Levetiracetam 500 in 1 BOTTLE TABLET 500 7 55111-248-30 Levetiracetam 30 in 1 BOTTLE TABLET 30 7 55111-248-60 Levetiracetam 60 in 1 BOTTLE TABLET 60 7 55111-248-79 Levetiracetam 10 in 1 BLISTER PACK TABLET 10 7 55111-248-79 Levetiracetam 1 in 1 CARTON TABLET 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded levetiracetam ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 levetiracetam ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 hypromellose 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 hypromellose 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 povidone INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-248 LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 7 Current NDC, Legacy NDC, 6 package rows 20181207_1f3c04d9-cccb-06a3-a0f3-f7c9228ee743.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 Units Marketing start Marketing end Sample Exclude flag Status 55111-248-01 55111024801 100 TABLET in 1 BOTTLE (55111-248-01) 100 tablet 2009-01-15 0000-00-00 No No Current 55111-248-05 55111024805 500 TABLET in 1 BOTTLE (55111-248-05) 500 tablet 2009-01-15 0000-00-00 No No Current 55111-248-30 55111024830 30 TABLET in 1 BOTTLE (55111-248-30) 30 tablet 2009-01-15 0000-00-00 No No Current 55111-248-60 55111024860 60 TABLET in 1 BOTTLE (55111-248-60) 60 tablet 2009-01-15 0000-00-00 No No Current 55111-248-79 55111024879 1 BLISTER PACK in 1 CARTON (55111-248-79) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2009-01-15 0000-00-00 No No Current