levetiracetam

Generic: levetiracetam

Labeler: sohm, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler sohm, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
SOHM, Inc.

Identifiers & Regulatory

Product NDC 50405-301
Product ID 50405-301_8d5b3de5-1dce-43e9-9858-c0439034f86a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079042
Listing Expiration 2026-12-31
Marketing Start 2024-05-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50405301
Hyphenated Format 50405-301

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
UPC
0350405301029 0350405302026 0350405300022
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 ANDA079042 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50405-301-01)
  • 120 TABLET in 1 BOTTLE (50405-301-02)
  • 500 TABLET in 1 BOTTLE (50405-301-03)
source: ndc

Packages (3)

50405-301-01 30 TABLET in 1 BOTTLE (50405-301-01) 50405-301-02 120 TABLET in 1 BOTTLE (50405-301-02) 50405-301-03 500 TABLET in 1 BOTTLE (50405-301-03)

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": "8d5b3de5-1dce-43e9-9858-c0439034f86a", "openfda": {"nui": ["N0000008486"], "upc": ["0350405301029", "0350405302026", "0350405300022"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["0a688786-879b-4e27-a46a-5c86bbfa1292"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["SOHM, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50405-301-01)", "package_ndc": "50405-301-01", "marketing_start_date": "20240527"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (50405-301-02)", "package_ndc": "50405-301-02", "marketing_start_date": "20240527"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (50405-301-03)", "package_ndc": "50405-301-03", "marketing_start_date": "20240527"}], "brand_name": "Levetiracetam", "product_id": "50405-301_8d5b3de5-1dce-43e9-9858-c0439034f86a", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50405-301", "generic_name": "Levetiracetam", "labeler_name": "SOHM, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA079042", "marketing_category": "ANDA", "marketing_start_date": "20240527", "listing_expiration_date": "20261231"}