Home NDC 43547-221 Levetiracetam
Product NDC 43547-221
11-digit product format 435470221
Labeler code 43547
Product ID 43547-221_da6c3e56-5044-4f0b-9f0e-7267e2fe89bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Solco Healthcare US, LLC
Application ANDA078106
Marketing category ANDA
Marketing start 2012-09-11
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 A078106-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 A078106-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 A078106-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 A078106-004 LEVETIRACETAM LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10
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 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078106-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078106-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078106-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078106-004 LEVETIRACETAM 1GM TABLET / ORAL AB 2009-02-10 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 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 · 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 43547-221-15 Levetiracetam 120 in 1 BOTTLE TABLET, FILM COATED 120 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVETIRACETAM ACTIVE INGREDIENT 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 LEVETIRACETAM ACTIVE MOIETY 44YRR34555 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 HYPROMELLOSE 2910 (50 MPA.S) INACTIVE INGREDIENT 1IVH67816N LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 POLYETHYLENE GLYCOL 800 INACTIVE INGREDIENT UH6KR4953D LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 POVIDONES INACTIVE INGREDIENT FZ989GH94E LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-221 LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 20 Current NDC, Legacy NDC, 1 package rows 20240420_dd713e60-478c-43cd-b680-ff594a0b3864.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 Marketing start Marketing end Sample Exclude flag Status 43547-221-15 43547022115 120 TABLET, FILM COATED in 1 BOTTLE (43547-221-15) 2012-09-11 0000-00-00 No No Current