levetiracetam

Generic: levetiracetam in sodium chloride

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam in sodium chloride
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 500 mg/100mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-173
Product ID 65145-173_b14657e5-789e-4933-aeb9-78509d79b792
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219562
Listing Expiration 2026-12-31
Marketing Start 2025-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145173
Hyphenated Format 65145-173

Supplemental Identifiers

RxCUI
1193358 1193360 1193362
UPC
0365145175014 0365145174017 0365145173010
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 in sodium chloride (source: ndc)
Application Number ANDA219562 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 10 POUCH in 1 CASE (65145-173-10) / 1 BAG in 1 POUCH (65145-173-01) / 100 mL in 1 BAG
source: ndc

Packages (1)

65145-173-10 10 POUCH in 1 CASE (65145-173-10) / 1 BAG in 1 POUCH (65145-173-01) / 100 mL in 1 BAG

Ingredients (1)

levetiracetam (500 mg/100mL)

Linked Drug Pages (1)

Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b14657e5-789e-4933-aeb9-78509d79b792", "openfda": {"nui": ["N0000008486"], "upc": ["0365145175014", "0365145174017", "0365145173010"], "unii": ["44YRR34555"], "rxcui": ["1193358", "1193360", "1193362"], "spl_set_id": ["563171fb-df26-4f95-853a-fd7707da291c"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CASE (65145-173-10)  / 1 BAG in 1 POUCH (65145-173-01)  / 100 mL in 1 BAG", "package_ndc": "65145-173-10", "marketing_start_date": "20250624"}], "brand_name": "Levetiracetam", "product_id": "65145-173_b14657e5-789e-4933-aeb9-78509d79b792", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65145-173", "generic_name": "Levetiracetam in Sodium Chloride", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/100mL"}], "application_number": "ANDA219562", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20261231"}