Home NDC 67877-769 Levetiracetam
Product NDC 67877-769
11-digit product format 678770769
Labeler code 67877
Product ID 67877-769_40d1180e-73b5-4e73-8d42-15b99313496f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA216375
Marketing category ANDA
Marketing start 2022-05-28
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 A216375-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 A216375-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 A216375-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 A216375-004 LEVETIRACETAM LEVETIRACETAM 1GM 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 3 · 116 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 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216375-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2022-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216375-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2022-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216375-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2022-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216375-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2022-05-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 116 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 67877-769-05 Levetiracetam 500 in 1 BOTTLE TABLET, FILM COATED 500 13 67877-769-12 Levetiracetam 120 in 1 BOTTLE TABLET, FILM COATED 120 13 67877-769-30 Levetiracetam 30 in 1 BOTTLE TABLET, FILM COATED 30 13 67877-769-33 Levetiracetam 1 in 1 CARTON TABLET, FILM COATED 1 13 67877-769-33 Levetiracetam 10 in 1 BLISTER PACK TABLET, FILM COATED 10 13 67877-769-38 Levetiracetam 10 in 1 BLISTER PACK TABLET, FILM COATED 10 13 67877-769-38 Levetiracetam 10 in 1 CARTON TABLET, FILM COATED 10 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-769 LEVETIRACETAM TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 13 Current NDC, Legacy NDC, 7 package rows 20241115_591dd9f1-3681-4b2f-b096-7536826e3648.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 · 1 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 67877-769-05 67877076905 500 TABLET, FILM COATED in 1 BOTTLE (67877-769-05) 2022-05-28 0000-00-00 No No Current 67877-769-12 67877076912 120 TABLET, FILM COATED in 1 BOTTLE (67877-769-12) 2022-05-28 0000-00-00 No No Current 67877-769-30 67877076930 30 TABLET, FILM COATED in 1 BOTTLE (67877-769-30) 2022-05-28 0000-00-00 No No Current 67877-769-33 67877076933 1 BLISTER PACK in 1 CARTON (67877-769-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2022-05-28 0000-00-00 No No Current 67877-769-38 67877076938 10 BLISTER PACK in 1 CARTON (67877-769-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2024-10-29 No No Current