levetiracetam

Generic: levetiracetam

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-529
Product ID 65162-529_3a499e5a-b4c5-46b8-b667-ee79134e488a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090767
Listing Expiration 2026-12-31
Marketing Start 2013-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162529
Hyphenated Format 65162-529

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
UPC
0365162528169 0365162529166 0365162538168 0365162539066
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 ANDA090767 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (65162-529-16)
source: ndc

Packages (1)

65162-529-16 120 TABLET, FILM COATED in 1 BOTTLE (65162-529-16)

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": "3a499e5a-b4c5-46b8-b667-ee79134e488a", "openfda": {"nui": ["N0000008486"], "upc": ["0365162528169", "0365162529166", "0365162538168", "0365162539066"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["d7932a2c-a3b7-46df-a306-1f17716160a0"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (65162-529-16)", "package_ndc": "65162-529-16", "marketing_start_date": "20130228"}], "brand_name": "Levetiracetam", "product_id": "65162-529_3a499e5a-b4c5-46b8-b667-ee79134e488a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65162-529", "generic_name": "Levetiracetam", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA090767", "marketing_category": "ANDA", "marketing_start_date": "20130228", "listing_expiration_date": "20261231"}