Home NDC 64980-604-50 Levetiracetam
Product NDC 64980-604
Requested package NDC 64980-604-50
11-digit product format 649800604
Labeler code 64980
Product ID 64980-604_22c1d3b2-17b6-46b6-9474-ebe6cda4b2c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA090767
Marketing category ANDA
Marketing start 2024-06-10
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090767-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 A090767-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 A090767-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 A090767-004 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28
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 · 172 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 2026-09-14 22:38:34 2026-08 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-604-01 Levetiracetam 100 in 1 BOTTLE TABLET, FILM COATED 100 7 64980-604-12 Levetiracetam 120 in 1 BOTTLE TABLET, FILM COATED 120 7 64980-604-50 Levetiracetam 500 in 1 BOTTLE TABLET, FILM COATED 500 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-604 LEVETIRACETAM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 6 Current NDC, 3 package rows 20250529_db423b93-d7c2-4cf2-829b-24b657f27f93.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 64980-604-50 64980060450 500 TABLET, FILM COATED in 1 BOTTLE (64980-604-50) 2024-06-10 No No Current