levetiracetam er

Generic: levetiracetam

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levetiracetam 750 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-333
Product ID 69367-333_18d684d2-22a4-497a-ab10-f35ef53408ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205130
Listing Expiration 2026-12-31
Marketing Start 2021-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367333
Hyphenated Format 69367-333

Supplemental Identifiers

RxCUI
807832 846378
UPC
0369367332606 0369367333603
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 er (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA205130 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-333-60)
source: ndc

Packages (1)

69367-333-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-333-60)

Ingredients (1)

levetiracetam (750 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": "18d684d2-22a4-497a-ab10-f35ef53408ce", "openfda": {"nui": ["N0000008486"], "upc": ["0369367332606", "0369367333603"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378"], "spl_set_id": ["c508a392-0603-477d-8a45-3ec550371111"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-333-60)", "package_ndc": "69367-333-60", "marketing_start_date": "20210930"}], "brand_name": "Levetiracetam ER", "product_id": "69367-333_18d684d2-22a4-497a-ab10-f35ef53408ce", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69367-333", "generic_name": "Levetiracetam", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "brand_name_suffix": "ER", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "750 mg/1"}], "application_number": "ANDA205130", "marketing_category": "ANDA", "marketing_start_date": "20210930", "listing_expiration_date": "20261231"}