levetiracetam extended-release

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam extended-release
Generic Name levetiracetam
Labeler omnivium pharmaceuticals llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 750 mg/1

Manufacturer
Omnivium Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 81665-100
Product ID 81665-100_c50830af-76fa-476a-a88d-50f38f9ecc42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212688
Listing Expiration 2027-12-31
Marketing Start 2020-06-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81665100
Hyphenated Format 81665-100

Supplemental Identifiers

RxCUI
807832 846378
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 extended-release (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA212688 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-12)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-60)
source: ndc

Packages (2)

81665-100-12 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-12) 81665-100-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-60)

Ingredients (1)

levetiracetam (750 mg/1)

Linked Drug Pages (1)

LEVETIRACETAM Extended-release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c50830af-76fa-476a-a88d-50f38f9ecc42", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378"], "spl_set_id": ["1a31134d-6b63-4d14-8445-0ed132e6c88d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Omnivium Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-12)", "package_ndc": "81665-100-12", "marketing_start_date": "20221024"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-60)", "package_ndc": "81665-100-60", "marketing_start_date": "20200611"}], "brand_name": "LEVETIRACETAM Extended-release", "product_id": "81665-100_c50830af-76fa-476a-a88d-50f38f9ecc42", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "81665-100", "generic_name": "LEVETIRACETAM", "labeler_name": "Omnivium Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "brand_name_suffix": "Extended-release", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "750 mg/1"}], "application_number": "ANDA212688", "marketing_category": "ANDA", "marketing_start_date": "20200611", "listing_expiration_date": "20271231"}