levetiracetam

Generic: levetiracetam

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levetiracetam 1000 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1461
Product ID 67046-1461_2d594515-8a06-02f6-e063-6294a90a7038
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091491
Listing Expiration 2026-12-31
Marketing Start 2025-02-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461461
Hyphenated Format 67046-1461

Supplemental Identifiers

RxCUI
387003
UNII
44YRR34555
NUI
N0000008486

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 ANDA091491 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1461-3)
source: ndc

Packages (1)

67046-1461-3 30 TABLET in 1 BLISTER PACK (67046-1461-3)

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": "2d594515-8a06-02f6-e063-6294a90a7038", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["387003"], "spl_set_id": ["2d596153-c49b-273f-e063-6294a90ac663"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1461-3)", "package_ndc": "67046-1461-3", "marketing_start_date": "20250204"}], "brand_name": "Levetiracetam", "product_id": "67046-1461_2d594515-8a06-02f6-e063-6294a90a7038", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67046-1461", "generic_name": "Levetiracetam", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "1000 mg/1"}], "application_number": "ANDA091491", "marketing_category": "ANDA", "marketing_start_date": "20250204", "listing_expiration_date": "20261231"}