levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

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

levetiracetam 100 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9574
Product ID 0143-9574_14e07144-d548-4e86-ab10-2e16ec58aab7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090981
Listing Expiration 2026-12-31
Marketing Start 2015-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439574
Hyphenated Format 0143-9574

Supplemental Identifiers

RxCUI
647121
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 ANDA090981 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)
source: ndc

Packages (2)

0143-9574-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01) 0143-9574-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)

Ingredients (1)

levetiracetam (100 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": "14e07144-d548-4e86-ab10-2e16ec58aab7", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["097e5606-dd5e-4518-ab97-f71f68786444"], "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 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)", "package_ndc": "0143-9574-10", "marketing_start_date": "20150601"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-25)  / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)", "package_ndc": "0143-9574-25", "marketing_start_date": "20150601"}], "brand_name": "Levetiracetam", "product_id": "0143-9574_14e07144-d548-4e86-ab10-2e16ec58aab7", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0143-9574", "generic_name": "Levetiracetam", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA090981", "marketing_category": "ANDA", "marketing_start_date": "20150601", "listing_expiration_date": "20261231"}