Home NDC 50228-471 Levetiracetam
Product NDC 50228-471
11-digit product format 502280471
Labeler code 50228
Product ID 50228-471_1ea253c3-3086-2b26-e063-6394a90a312e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ScieGen Pharmaceuticals, Inc.
Application ANDA215069
Marketing category ANDA
Marketing start 2022-05-27
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 A215069-001 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 A215069-002 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 A215069-003 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 A215069-004 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27
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 4 · 124 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 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215069-001 LEVETIRACETAM 750MG TABLET / ORAL AB 2021-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215069-002 LEVETIRACETAM 1GM TABLET / ORAL AB 2021-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215069-003 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215069-004 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 122 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 · 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50228-471-05 Levetiracetam 500 in 1 BOTTLE TABLET, FILM COATED 500 5 50228-471-10 Levetiracetam 1000 in 1 BOTTLE TABLET, FILM COATED 1000 5 50228-471-12 Levetiracetam 120 in 1 BOTTLE TABLET, FILM COATED 120 5 50228-471-30 Levetiracetam 30 in 1 BOTTLE TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50228-471 LEVETIRACETAM TABLET, FILM COATED LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20240802_1d71212b-ac97-4a61-8192-8e8303540019.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 50228-471-05 50228047105 500 TABLET, FILM COATED in 1 BOTTLE (50228-471-05) 2022-05-27 0000-00-00 No No Current 50228-471-10 50228047110 1000 TABLET, FILM COATED in 1 BOTTLE (50228-471-10) 2022-05-27 0000-00-00 No No Current 50228-471-12 50228047112 120 TABLET, FILM COATED in 1 BOTTLE (50228-471-12) 2022-05-27 0000-00-00 No No Current 50228-471-30 50228047130 30 TABLET, FILM COATED in 1 BOTTLE (50228-471-30) 2022-05-27 0000-00-00 No No Current