Home NDC 65162-539 Levetiracetam
Product NDC 65162-539
11-digit product format 651620539
Labeler code 65162
Product ID 65162-539_3a499e5a-b4c5-46b8-b667-ee79134e488a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA090767
Marketing category ANDA
Marketing start 2013-02-28
Substance LEVETIRACETAM
Active strength 1000 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 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 · 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 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090767-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090767-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090767-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090767-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2010-07-28 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 1000 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 65162-539-06 Levetiracetam 60 in 1 BOTTLE TABLET, FILM COATED 60 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-539 LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] 26 Current NDC, Legacy NDC, 1 package rows 20241030_d7932a2c-a3b7-46df-a306-1f17716160a0.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 Marketing end Sample Exclude flag Status 65162-539-06 65162053906 60 TABLET, FILM COATED in 1 BOTTLE (65162-539-06) 2013-02-28 0000-00-00 No No Current