levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler granules pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-522
Product ID 70010-522_451c385c-1c8a-5eca-e063-6294a90a3a4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217878
Listing Expiration 2026-12-31
Marketing Start 2024-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010522
Hyphenated Format 70010-522

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
UPC
0370010524033 0370010521032 0370010522039
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 ANDA217878 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70010-522-03)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70010-522-10)
source: ndc

Packages (2)

70010-522-03 30 TABLET, FILM COATED in 1 BOTTLE (70010-522-03) 70010-522-10 1000 TABLET, FILM COATED in 1 BOTTLE (70010-522-10)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "451c385c-1c8a-5eca-e063-6294a90a3a4f", "openfda": {"nui": ["N0000008486"], "upc": ["0370010524033", "0370010521032", "0370010522039"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["b4781ec4-43ad-4052-9a6a-b24fda119b32"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70010-522-03)", "package_ndc": "70010-522-03", "marketing_start_date": "20240624"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70010-522-10)", "package_ndc": "70010-522-10", "marketing_start_date": "20240624"}], "brand_name": "Levetiracetam", "product_id": "70010-522_451c385c-1c8a-5eca-e063-6294a90a3a4f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70010-522", "generic_name": "Levetiracetam", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA217878", "marketing_category": "ANDA", "marketing_start_date": "20240624", "listing_expiration_date": "20261231"}