Home NDC 66689-030 Levetiracetam
Product NDC 66689-030
11-digit product format 666890030
Labeler code 66689
Product ID 66689-030_c0232b95-ecd0-413d-a8ea-e6721aa21fdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form SOLUTION
Route ORAL
Labeler VistaPharm, LLC
Application ANDA078976
Marketing category ANDA
Marketing start 2010-01-25
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 2023-12-31
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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 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 66689-030-50 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A078976-001 LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 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 A078976-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078976-001 LEVETIRACETAM 100MG/ML SOLUTION / ORAL AA 2009-01-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Levetiracetam ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 Levetiracetam ACTIVE MOIETY 44YRR34555 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 glycyrrhizin, ammoniated INACTIVE INGREDIENT 3VRD35U26C LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 maltitol INACTIVE INGREDIENT D65DG142WK LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2 water INACTIVE INGREDIENT 059QF0KO0R LEVETIRACETAM SOLUTION [VISTAPHARM, INC] 2
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66689-030-50 66689003050 5 TRAY in 1 CASE (66689-030-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (66689-030-01) 5 tray 2010-01-25 0000-00-00 No No Current