Home NDC 71930-065 Levetiracetam
Product NDC 71930-065
11-digit product format 719300065
Labeler code 71930
Product ID 71930-065_bc9d8d29-4a90-6efc-e053-2a95a90a0ff2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET
Route ORAL
Labeler EYWA Pharma Inc.
Application ANDA090767
Marketing category ANDA
Marketing start 2019-12-05
Marketing end 0000-00-00
Substance LEVETIRACETAM
Active strength 1000 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 24 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 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 71930-065-60 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090767-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 A090767-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 A090767-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 A090767-004 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 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 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Product Concepts# 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 Units Marketing start Marketing end Sample Exclude flag Status 71930-065-60 71930006560 60 TABLET in 1 BOTTLE (71930-065-60) 60 tablet 2019-12-05 0000-00-00 No No Current