Home NDC 17856-0574 Levetiracetam
Product NDC 17856-0574
11-digit product format 178560574
Labeler code 17856
Product ID 17856-0574_3624ffe5-0cb0-b7c0-e063-6394a90a69bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler Atlantic Biologicals Corp.
Application ANDA203052
Marketing category ANDA
Marketing start 2015-06-11
Substance LEVETIRACETAM
Active strength 100 mg/mL
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0574-1 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-0574-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 17856-0574-1 9bebd1f3094a…5416666fcb17…
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 A203052-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203052-001 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 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 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
Brand name suffix Levetiracetam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 100 mg/mL
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0574-1 LevetiracetamLevetiracetam 72 in 1 BOX, UNIT-DOSE SOLUTION 72 4 17856-0574-2 LevetiracetamLevetiracetam 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0574 LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [ATLANTIC BIOLOGICALS CORP.] 4 Current NDC, Legacy NDC, 2 package rows 20250529_56fed03f-38c3-4273-8fd7-522bc508bf36.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 Units Marketing start Marketing end Sample Exclude flag Status 17856-0574-1 17856057401 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0574-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0574-2) 2021-08-25 0000-00-00 No No Current 17856-0574-2 17856057402 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical