Home NDC 55111-182-30 Levetiracetam
Product NDC 55111-182
Requested package NDC 55111-182-30
11-digit product format 551110182
Labeler code 55111
Product ID 55111-182_2de4ebba-b125-4355-35f5-69b92e56634b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levetiracetam
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA076920
Marketing category ANDA
Marketing start 2009-01-15
Substance LEVETIRACETAM
Active strength 500 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076920-001 LEVETIRACETAM LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 A076920-002 LEVETIRACETAM LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 A076920-003 LEVETIRACETAM LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076920-002 LEVETIRACETAM 500MG TABLET / ORAL AB 2009-01-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076920-003 LEVETIRACETAM 750MG TABLET / ORAL AB 2009-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076920-001 LEVETIRACETAM 250MG TABLET / ORAL AB 2009-01-15 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Levetiracetam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 500 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311288 Internal RxNorm lookup 311289 Internal RxNorm lookup 311290 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 55111-182-01 Levetiracetam 100 in 1 BOTTLE TABLET 100 7 55111-182-04 Levetiracetam 120 in 1 BOTTLE TABLET 120 7 55111-182-05 Levetiracetam 500 in 1 BOTTLE TABLET 500 7 55111-182-30 Levetiracetam 30 in 1 BOTTLE TABLET 30 7 55111-182-79 Levetiracetam 1 in 1 CARTON TABLET 1 7 55111-182-79 Levetiracetam 10 in 1 BLISTER PACK TABLET 10 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-182 LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED] 7 Current NDC, Legacy NDC, 6 package rows 20181207_ee03507b-cb35-4fe9-ae7b-85ea89f876f0.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 · 1 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 55111-182-30 55111018230 30 TABLET in 1 BOTTLE (55111-182-30) 30 tablet 2009-01-15 0000-00-00 No No Current