levetiracetam

Generic: levetiracetam

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 1000 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-315
Product ID 65862-315_61244070-03c7-41d1-a784-b46dfc93fcbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078993
Listing Expiration 2026-12-31
Marketing Start 2009-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862315
Hyphenated Format 65862-315

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
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 ANDA078993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-315-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-315-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (65862-315-60)
source: ndc

Packages (3)

65862-315-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-315-05) 65862-315-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-315-30) 65862-315-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-315-60)

Ingredients (1)

levetiracetam (1000 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": "61244070-03c7-41d1-a784-b46dfc93fcbc", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["2471ee03-d747-4113-86d0-1aa93c8f3eba"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-315-05)", "package_ndc": "65862-315-05", "marketing_start_date": "20090115"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-315-30)", "package_ndc": "65862-315-30", "marketing_start_date": "20090115"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-315-60)", "package_ndc": "65862-315-60", "marketing_start_date": "20090115"}], "brand_name": "Levetiracetam", "product_id": "65862-315_61244070-03c7-41d1-a784-b46dfc93fcbc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65862-315", "generic_name": "Levetiracetam", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "1000 mg/1"}], "application_number": "ANDA078993", "marketing_category": "ANDA", "marketing_start_date": "20090115", "listing_expiration_date": "20261231"}