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 SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9615
Product ID 63629-9615_161755bf-d54f-496b-be13-a9377019098b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078582
Listing Expiration 2026-12-31
Marketing Start 2009-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636299615
Hyphenated Format 63629-9615

Supplemental Identifiers

RxCUI
403884
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 ANDA078582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (63629-9615-1)
source: ndc

Packages (1)

63629-9615-1 473 mL in 1 BOTTLE (63629-9615-1)

Ingredients (1)

levetiracetam (100 mg/mL)

Linked Drug Pages (1)

Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "161755bf-d54f-496b-be13-a9377019098b", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["f7c96494-6cb2-4d00-8c5a-5bec4e0c70c0"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (63629-9615-1)", "package_ndc": "63629-9615-1", "marketing_start_date": "20230203"}], "brand_name": "Levetiracetam", "product_id": "63629-9615_161755bf-d54f-496b-be13-a9377019098b", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "63629-9615", "generic_name": "Levetiracetam", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA078582", "marketing_category": "ANDA", "marketing_start_date": "20090115", "listing_expiration_date": "20261231"}