Home NDC 13668-017 Levetiracetam
Product NDC 13668-017
11-digit product format 136680017
Labeler code 13668
Product ID 13668-017_b8792837-f86a-4e67-b1a5-ec8ca278fe77
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA078858
Marketing category ANDA
Marketing start 2009-01-15
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 42 .
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 · 168 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 2026-08-18 06:07:40 2026-07 A078858-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078858-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078858-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078858-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-01-15 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 13668-017-05 Levetiracetam 500 in 1 BOTTLE TABLET 500 27 13668-017-12 Levetiracetam 120 in 1 BOTTLE TABLET 120 27 13668-017-25 Levetiracetam 250 in 1 BOTTLE TABLET 250 27 13668-017-60 Levetiracetam 60 in 1 BOTTLE TABLET 60 27 13668-017-65 Levetiracetam 650 in 1 BOTTLE TABLET 650 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 13 LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.] 7 LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP] 1 LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-017 LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED] 27 Current NDC, Legacy NDC, 5 package rows 20250201_6ab24168-058d-496e-9023-da8ee6353eb3.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 13668-017-05 13668001705 500 TABLET in 1 BOTTLE (13668-017-05) 500 tablet 2009-01-15 0000-00-00 No No Current 13668-017-12 13668001712 120 TABLET in 1 BOTTLE (13668-017-12) 120 tablet 2009-01-15 0000-00-00 No No Current 13668-017-25 13668001725 250 TABLET in 1 BOTTLE (13668-017-25) 250 tablet 2009-01-15 0000-00-00 No No Current 13668-017-60 13668001760 60 TABLET in 1 BOTTLE (13668-017-60) 60 tablet 2009-01-15 0000-00-00 No No Current 13668-017-61 13668001761 50 TABLET in 1 CARTON (13668-017-61) 50 tablet 2009-01-15 0000-00-00 No No Current 13668-017-65 13668001765 650 TABLET in 1 BOTTLE (13668-017-65) 650 tablet 2009-01-15 0000-00-00 No No Current