levetiracetam

Generic: levetiracetam

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 15 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 36000-354
Product ID 36000-354_38597db4-72c4-438f-9172-16c936f2a925
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217059
Listing Expiration 2026-12-31
Marketing Start 2023-10-02

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36000354
Hyphenated Format 36000-354

Supplemental Identifiers

RxCUI
1193358 1193360 1193362
UNII
44YRR34555
NUI
N0000008486

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name levetiracetam (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA217059 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CARTON (36000-354-40) / 100 mL in 1 BAG (36000-354-01)
source: ndc

Packages (1)

36000-354-40 24 BAG in 1 CARTON (36000-354-40) / 100 mL in 1 BAG (36000-354-01)

Ingredients (1)

levetiracetam (15 mg/mL)

Linked Drug Pages (1)

levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "38597db4-72c4-438f-9172-16c936f2a925", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["1193358", "1193360", "1193362"], "spl_set_id": ["3d88adda-9580-44bf-b75c-d615c973c1e1"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CARTON (36000-354-40)  / 100 mL in 1 BAG (36000-354-01)", "package_ndc": "36000-354-40", "marketing_start_date": "20231002"}], "brand_name": "levetiracetam", "product_id": "36000-354_38597db4-72c4-438f-9172-16c936f2a925", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "36000-354", "generic_name": "levetiracetam", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "15 mg/mL"}], "application_number": "ANDA217059", "marketing_category": "ANDA", "marketing_start_date": "20231002", "listing_expiration_date": "20261231"}