levetiracetam

Generic: levetiracetam

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler apotex corp.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3280
Product ID 60505-3280_2e47ee1c-2875-27e8-6069-a491f7ef3b6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091261
Listing Expiration 2026-12-31
Marketing Start 2011-09-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605053280
Hyphenated Format 60505-3280

Supplemental Identifiers

RxCUI
807832 846378 1605362
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 ANDA091261 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-5)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-6)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-8)
source: ndc

Packages (3)

60505-3280-5 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-5) 60505-3280-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-6) 60505-3280-8 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-8)

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": "2e47ee1c-2875-27e8-6069-a491f7ef3b6f", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378", "1605362"], "spl_set_id": ["abc9fada-c5c2-4e07-fb8a-4d1518f7657e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-5)", "package_ndc": "60505-3280-5", "marketing_start_date": "20110912"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-6)", "package_ndc": "60505-3280-6", "marketing_start_date": "20110912"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3280-8)", "package_ndc": "60505-3280-8", "marketing_start_date": "20110912"}], "brand_name": "Levetiracetam", "product_id": "60505-3280_2e47ee1c-2875-27e8-6069-a491f7ef3b6f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "60505-3280", "generic_name": "Levetiracetam", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA091261", "marketing_category": "ANDA", "marketing_start_date": "20110912", "listing_expiration_date": "20261231"}