levetiracetam

Generic: levetiracetam

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 1000 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-7516
Product ID 63629-7516_d310428a-bf9e-4838-b409-3282dde4890b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078106
Listing Expiration 2026-12-31
Marketing Start 2012-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636297516
Hyphenated Format 63629-7516

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 ANDA078106 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-7516-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63629-7516-2)
  • 58 TABLET, FILM COATED in 1 BOTTLE (63629-7516-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63629-7516-4)
source: ndc

Packages (4)

63629-7516-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-7516-1) 63629-7516-2 90 TABLET, FILM COATED in 1 BOTTLE (63629-7516-2) 63629-7516-3 58 TABLET, FILM COATED in 1 BOTTLE (63629-7516-3) 63629-7516-4 60 TABLET, FILM COATED in 1 BOTTLE (63629-7516-4)

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": "d310428a-bf9e-4838-b409-3282dde4890b", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["387003"], "spl_set_id": ["ed8e88d0-993e-4683-bdcf-31578130d3df"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-7516-1)", "package_ndc": "63629-7516-1", "marketing_start_date": "20240403"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63629-7516-2)", "package_ndc": "63629-7516-2", "marketing_start_date": "20180123"}, {"sample": false, "description": "58 TABLET, FILM COATED in 1 BOTTLE (63629-7516-3)", "package_ndc": "63629-7516-3", "marketing_start_date": "20240403"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63629-7516-4)", "package_ndc": "63629-7516-4", "marketing_start_date": "20240403"}], "brand_name": "Levetiracetam", "product_id": "63629-7516_d310428a-bf9e-4838-b409-3282dde4890b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "63629-7516", "generic_name": "Levetiracetam", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "1000 mg/1"}], "application_number": "ANDA078106", "marketing_category": "ANDA", "marketing_start_date": "20120911", "listing_expiration_date": "20261231"}