Home NDC 55154-5782 Levetiracetam
Product NDC 55154-5782
11-digit product format 551545782
Labeler code 55154
Product ID 55154-5782_402eff19-cfb5-4cde-a53c-2a73f78b468f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVETIRACETAM
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA201157
Marketing category ANDA
Marketing start 2015-06-04
Substance LEVETIRACETAM
Active strength 500 mg/5mL
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 A201157-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201157-001 AA
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 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201157-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2015-06-04 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 500 mg/5mL
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 403884 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 55154-5782-5 Levetiracetam 5 in 1 BAG SOLUTION 5 8 55154-5782-5 Levetiracetam 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-5782 LEVETIRACETAM SOLUTION [CARDINAL HEALTH 107, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250403_f924d55d-d7ec-4448-b54e-3a7eaf5a1cab.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 55154-5782-5 55154578205 5 CUP, UNIT-DOSE in 1 BAG (55154-5782-5) / 5 mL in 1 CUP, UNIT-DOSE 2015-06-04 0000-00-00 No No Current