levetiracetam

Generic: levetiracetam

Labeler: b. braun medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler b. braun medical inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 5 mg/mL

Manufacturer
B. Braun Medical Inc.

Identifiers & Regulatory

Product NDC 0264-5009
Product ID 0264-5009_c37794a6-677a-4669-83c6-8fbff7ab24fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209705
Listing Expiration 2026-12-31
Marketing Start 2024-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02645009
Hyphenated Format 0264-5009

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 ANDA209705 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 24 CONTAINER in 1 CASE (0264-5009-90) / 100 mL in 1 CONTAINER
source: ndc

Packages (1)

0264-5009-90 24 CONTAINER in 1 CASE (0264-5009-90) / 100 mL in 1 CONTAINER

Ingredients (1)

levetiracetam (5 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": "c37794a6-677a-4669-83c6-8fbff7ab24fd", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["1193358", "1193360", "1193362"], "spl_set_id": ["ad32ec2f-b4e0-4811-8ea1-7a4abdd5c0a6"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["B. Braun Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 CONTAINER in 1 CASE (0264-5009-90)  / 100 mL in 1 CONTAINER", "package_ndc": "0264-5009-90", "marketing_start_date": "20240513"}], "brand_name": "Levetiracetam", "product_id": "0264-5009_c37794a6-677a-4669-83c6-8fbff7ab24fd", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0264-5009", "generic_name": "Levetiracetam", "labeler_name": "B. Braun Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "5 mg/mL"}], "application_number": "ANDA209705", "marketing_category": "ANDA", "marketing_start_date": "20240513", "listing_expiration_date": "20261231"}