Home NDC 70166-081 Levetiracetam
Product NDC 70166-081
11-digit product format 701660081
Labeler code 70166
Product ID 70166-081_9582e172-999c-7b0d-e053-2995a90a6cb4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler Lohxa
Application ANDA203052
Marketing category ANDA
Marketing start 2015-06-11
Marketing end 0000-00-00
Substance LEVETIRACETAM
Active strength 100 mg/mL
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 30 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70166-081-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70166-081-05 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70166-081-05 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70166-081-05 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70166-081-05 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70166-081-05 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70166-081-05 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70166-081-05 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70166-081-05 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70166-081-05 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70166-081-05 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70166-081-05 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 70166-081-05 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 70166-081-05 834df4deac94…adcc014656a3…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 70166-081-05 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203052-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2013-02-28 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 70166-081-05 LevetiracetamLevetiracetam 50 in 1 BOX SOLUTION 50 1 70166-081-05 LevetiracetamLevetiracetam 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70166-081 LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [LOHXA] 1 Legacy NDC, 2 package rows 20191024_9679202b-2208-43e5-841b-2faab0e516f3.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 · 3 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 70166-081-05 70166008105 50 CUP, UNIT-DOSE in 1 BOX (70166-081-05) > 5 mL in 1 CUP, UNIT-DOSE 2019-10-22 0000-00-00 No No Current