levetiracetam

Generic: levetiracetam

Labeler: hp halden pharma as
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler hp halden pharma as
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 10 mg/mL

Manufacturer
Hp Halden Pharma AS

Identifiers & Regulatory

Product NDC 66298-0447
Product ID 66298-0447_4420fb70-8e1b-709c-e063-6394a90a1e7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208619
Listing Expiration 2026-12-31
Marketing Start 2025-12-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 662980447
Hyphenated Format 66298-0447

Supplemental Identifiers

RxCUI
1193358
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 ANDA208619 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CARTON (66298-0447-1) / 100 mL in 1 BAG
source: ndc

Packages (1)

66298-0447-1 24 BAG in 1 CARTON (66298-0447-1) / 100 mL in 1 BAG

Ingredients (1)

levetiracetam (10 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": "4420fb70-8e1b-709c-e063-6394a90a1e7a", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["1193358"], "spl_set_id": ["6951de41-4a16-4cca-8039-44fc81407081"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Hp Halden Pharma AS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CARTON (66298-0447-1)  / 100 mL in 1 BAG", "package_ndc": "66298-0447-1", "marketing_start_date": "20251212"}], "brand_name": "Levetiracetam", "product_id": "66298-0447_4420fb70-8e1b-709c-e063-6394a90a1e7a", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "66298-0447", "generic_name": "LEVETIRACETAM", "labeler_name": "Hp Halden Pharma AS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "10 mg/mL"}], "application_number": "ANDA208619", "marketing_category": "ANDA", "marketing_start_date": "20251212", "listing_expiration_date": "20261231"}