levetiracetam er

Generic: levetiracetam er

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam er
Generic Name levetiracetam er
Labeler direct_rx
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-510
Product ID 72189-510_2c4e5941-7089-8be7-e063-6394a90a92e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203468
Listing Expiration 2026-12-31
Marketing Start 2023-08-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189510
Hyphenated Format 72189-510

Supplemental Identifiers

RxCUI
807832
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 er (source: ndc)
Generic Name levetiracetam er (source: ndc)
Application Number ANDA203468 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-510-60)
source: ndc

Packages (1)

72189-510-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-510-60)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Levetiracetam ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4e5941-7089-8be7-e063-6394a90a92e3", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["807832"], "spl_set_id": ["03c449a1-9b40-a7da-e063-6394a90a984e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-510-60)", "package_ndc": "72189-510-60", "marketing_start_date": "20230825"}], "brand_name": "Levetiracetam ER", "product_id": "72189-510_2c4e5941-7089-8be7-e063-6394a90a92e3", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72189-510", "generic_name": "Levetiracetam ER", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam ER", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA203468", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}