Home NDC 36000-354-40 levetiracetam
Product NDC 36000-354
Requested package NDC 36000-354-40
11-digit product format 360000354
Labeler code 36000
Product ID 36000-354_38597db4-72c4-438f-9172-16c936f2a925
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levetiracetam
Dosage form INJECTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA217059
Marketing category ANDA
Marketing start 2023-10-02
Substance LEVETIRACETAM
Active strength 15 mg/mL
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 45 .
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 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02
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 2 · 72 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 2026-11-14 07:37:17 2026-10 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217059-002 LEVETIRACETAM IN SODIUM CHLORIDE 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217059-003 LEVETIRACETAM IN SODIUM CHLORIDE 1.5GM/100ML (15MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217059-001 LEVETIRACETAM IN SODIUM CHLORIDE 500MG/100ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-10-02 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 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 15 mg/mL
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 1193358 Internal RxNorm lookup 1193360 Internal RxNorm lookup 1193362 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 36000-354-01 levetiracetam 100 mL in 1 BAG INJECTION 100 6 36000-354-40 levetiracetam 24 in 1 CARTON INJECTION 24 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36000-354 LEVETIRACETAM INJECTION [BAXTER HEALTHCARE CORPORATION] 5 Current NDC, 2 package rows 20250504_3d88adda-9580-44bf-b75c-d615c973c1e1.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 Sample Exclude flag Status 36000-354-40 36000035440 24 BAG in 1 CARTON (36000-354-40) / 100 mL in 1 BAG (36000-354-01) 24 bag 2023-10-02 No No Current