levetiracetam

Generic: levetiracetam

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-042
Product ID 65219-042_f70fc17f-13f6-4641-8606-993b939b509a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208619
Listing Expiration 2027-12-31
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 65219042
Hyphenated Format 65219-042

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 ANDA208619 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CARTON (65219-042-71) / 100 mL in 1 BAG (65219-042-21)
source: ndc

Packages (1)

65219-042-71 24 BAG in 1 CARTON (65219-042-71) / 100 mL in 1 BAG (65219-042-21)

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": "f70fc17f-13f6-4641-8606-993b939b509a", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["1193358", "1193360", "1193362"], "spl_set_id": ["da858849-1d18-4d38-b53d-d4dd1cd8fabc"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CARTON (65219-042-71)  / 100 mL in 1 BAG (65219-042-21)", "package_ndc": "65219-042-71", "marketing_start_date": "20251212"}], "brand_name": "Levetiracetam", "product_id": "65219-042_f70fc17f-13f6-4641-8606-993b939b509a", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65219-042", "generic_name": "levetiracetam", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "5 mg/mL"}], "application_number": "ANDA208619", "marketing_category": "ANDA", "marketing_start_date": "20251212", "listing_expiration_date": "20271231"}