Home NDC 76494-528 Levetiracetam
Product NDC 76494-528
11-digit product format 764940528
Labeler code 76494
Product ID 76494-528_bf716ab6-d438-4a19-8193-dbc05b4eabad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Prinston Pharmaceutical Inc.
Application ANDA078106
Marketing category ANDA
Marketing start 2012-09-11
Substance LEVETIRACETAM
Active strength 250 mg/1
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 76494-528-12 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 76494-528-12 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A078106-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 A078106-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 A078106-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 A078106-004 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10
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 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Levetiracetam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 250 mg/1
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311288 Internal RxNorm lookup 311289 Internal RxNorm lookup 311290 Internal RxNorm lookup 387003 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 76494-528-12 Levetiracetam 120 in 1 BOTTLE TABLET, FILM COATED 120 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 HYPROMELLOSE 2910 (50 MPA.S) INACTIVE INGREDIENT 1IVH67816N LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 POLYETHYLENE GLYCOL 800 INACTIVE INGREDIENT UH6KR4953D LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 POVIDONES INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76494-528 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 12 Current NDC, Legacy NDC, 1 package rows 20200826_d818ef84-9b3e-434b-92d9-910cfa8af7da.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 76494-528-12 76494052812 120 TABLET, FILM COATED in 1 BOTTLE (76494-528-12) 2012-09-11 0000-00-00 No No Current