Home NDC 13811-621 LEVETIRACETAM
Product NDC 13811-621
11-digit product format 138110621
Labeler code 13811
Product ID 13811-621_aee7e0ad-d868-4652-be59-ba508d0beacb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Trigen Laboratories, Inc.
Application ANDA090906
Marketing category ANDA
Marketing start 2012-03-31
Marketing end 0000-00-00
Substance LEVETIRACETAM
Active strength 500 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A090906-001 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 A090906-002 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 A090906-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 A090906-004 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31
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 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090906-001 LEVETIRACETAM 500MG TABLET / ORAL 2010-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090906-002 LEVETIRACETAM 250MG TABLET / ORAL 2016-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090906-003 LEVETIRACETAM 750MG TABLET / ORAL 2016-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090906-004 LEVETIRACETAM 1GM TABLET / ORAL 2016-10-31 5bbf6a4d5a75…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Levetiracetam ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Levetiracetam ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Ferric Oxide Yellow INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Povidones INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Triacetin INACTIVE INGREDIENT XHX3C3X673 LEVETIRACETAM TABLET, FILM COATED [TRIGEN LABORATORIES, INC.] 1
DailyMed RxNorm Mappings#