Home NDC 43063-499 Levetiracetam
Product NDC 43063-499
11-digit product format 430630499
Labeler code 43063
Product ID 43063-499_2f364228-05e4-2e79-e063-6294a90ac493
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA078858
Marketing category ANDA
Marketing start 2009-01-15
Substance LEVETIRACETAM
Active strength 500 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 A078858-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 A078858-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 A078858-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 A078858-004 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15
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 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 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 500 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311289 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43063-499-60 Levetiracetam 60 in 1 BOTTLE, PLASTIC TABLET 60 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-499 LEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.] 26 Current NDC, Legacy NDC, 1 package rows 20250418_c2177034-e164-453c-be02-1cf91ce27a07.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 Units Marketing start Marketing end Sample Exclude flag Status 43063-499-60 43063049960 60 TABLET in 1 BOTTLE, PLASTIC (43063-499-60) 60 tablet 2012-02-09 0000-00-00 No No Current