Home NDC 69102-108 Roweepra
Product NDC 69102-108
11-digit product format 691020108
Labeler code 69102
Product ID 69102-108_c7262ce0-c186-487b-9808-b340d31d8fe4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET
Route ORAL
Labeler OWP Pharmaceuticals, Inc.
Application ANDA078858
Marketing category ANDA
Marketing start 2020-10-28
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 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 Roweepra
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 · 5 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 1875868 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 69102-108-01 Roweepra 120 in 1 BOTTLE TABLET 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69102-108 ROWEEPRA (LEVETIRACETAM) TABLET LEVETIRACETAM TABLET [OWP PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250525_e662bf5b-c81c-4bcd-ba2e-552df95ca6f9.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 69102-108-01 69102010801 120 TABLET in 1 BOTTLE (69102-108-01) 120 tablet 2020-10-28 0000-00-00 No No Current