levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler hisun pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-148
Product ID 42658-148_2ca64aeb-e1b4-9e90-e063-6294a90ae80a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207175
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42658148
Hyphenated Format 42658-148

Supplemental Identifiers

RxCUI
807832 846378
UPC
0342658148032 0342658149077 0342658148070 0342658149039
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 ANDA207175 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42658-148-03)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42658-148-07)
source: ndc

Packages (2)

42658-148-03 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42658-148-03) 42658-148-07 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42658-148-07)

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": "2ca64aeb-e1b4-9e90-e063-6294a90ae80a", "openfda": {"nui": ["N0000008486"], "upc": ["0342658148032", "0342658149077", "0342658148070", "0342658149039"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378"], "spl_set_id": ["a5b05743-3aa0-6eb4-e053-2995a90a8a28"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42658-148-03)", "package_ndc": "42658-148-03", "marketing_start_date": "20250101"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42658-148-07)", "package_ndc": "42658-148-07", "marketing_start_date": "20250101"}], "brand_name": "LEVETIRACETAM", "product_id": "42658-148_2ca64aeb-e1b4-9e90-e063-6294a90ae80a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "42658-148", "generic_name": "LEVETIRACETAM", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA207175", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}