Home NDC 36000-265 LEVETIRACETAM
Product NDC 36000-265
11-digit product format 360000265
Labeler code 36000
Product ID 36000-265_3312be87-d596-4fbe-91f6-9bacf7ac8869
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levetiracetam
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA208458
Marketing category ANDA
Marketing start 2026-08-06
Substance LEVETIRACETAM
Active strength 100 mg/mL
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208458-001 LEVETIRACETAM LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2026-08-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208458-001 AP
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.
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 A208458-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2026-08-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208458-001 LEVETIRACETAM 500MG/5ML (100MG/ML) INJECTABLE / INTRAVENOUS AP 2026-08-06 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A208458-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208458-001 AP 1 caaa826d4ba7…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVETIRACETAM 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 647121 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 36000-265-05 36000026505 5 VIAL, SINGLE-DOSE in 1 CARTON (36000-265-05) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-265-01) 2026-08-06 No No Current 36000-265-10 36000026510 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-265-10) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-265-01) 2026-08-06 No No Current