levetiracetam in sodium chloride

Generic: levetiracetam in sodium chloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam in sodium chloride
Generic Name levetiracetam in sodium chloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9281
Product ID 0143-9281_f3105bfa-50ba-4e2f-8eae-0313242d8dcf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211356
Listing Expiration 2026-12-31
Marketing Start 2025-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439281
Hyphenated Format 0143-9281

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 in sodium chloride (source: ndc)
Generic Name levetiracetam in sodium chloride (source: ndc)
Application Number ANDA211356 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 BOX (0143-9281-10) / 100 mL in 1 BAG (0143-9281-01)
source: ndc

Packages (1)

0143-9281-10 10 BAG in 1 BOX (0143-9281-10) / 100 mL in 1 BAG (0143-9281-01)

Ingredients (1)

levetiracetam (5 mg/mL)

Linked Drug Pages (1)

Levetiracetam in Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f3105bfa-50ba-4e2f-8eae-0313242d8dcf", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["1193358", "1193360", "1193362"], "spl_set_id": ["c723fd27-214c-45f6-b170-a3b807ffab07"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 BOX (0143-9281-10)  / 100 mL in 1 BAG (0143-9281-01)", "package_ndc": "0143-9281-10", "marketing_start_date": "20250208"}], "brand_name": "Levetiracetam in Sodium Chloride", "product_id": "0143-9281_f3105bfa-50ba-4e2f-8eae-0313242d8dcf", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0143-9281", "generic_name": "Levetiracetam in Sodium Chloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam in Sodium Chloride", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "5 mg/mL"}], "application_number": "ANDA211356", "marketing_category": "ANDA", "marketing_start_date": "20250208", "listing_expiration_date": "20261231"}