Home NDC 76494-530 Levetiracetam
Product NDC 76494-530
11-digit product format 764940530
Labeler code 76494
Product ID 76494-530_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 750 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 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.
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 2026-08-01 22:54:32 2026-06 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 a50c72e98297…2026-08-01 22:54:32 2026-06 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 a50c72e98297…2026-08-01 22:54:32 2026-06 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 a50c72e98297…2026-08-01 22:54:32 2026-06 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Levetiracetam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 750 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 76494-530-12 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 76494-530 LEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.] 12 Current NDC, Legacy NDC, 1 package rows 20200826_d818ef84-9b3e-434b-92d9-910cfa8af7da.zip
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 76494-530-12 76494053012 120 TABLET, FILM COATED in 1 BOTTLE (76494-530-12) 2012-09-11 0000-00-00 No No Current