levetiracetam

Generic: levetiracetam

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 250 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-034
Product ID 16714-034_40911071-2280-bd37-e063-6394a90a0156
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090515
Listing Expiration 2026-12-31
Marketing Start 2022-03-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714034
Hyphenated Format 16714-034

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
UPC
0316714034010 0316714035024 0316714034027 0316714537016 0316714310015 0316714035017 0316714537023
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 (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA090515 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (16714-034-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16714-034-02)
source: ndc

Packages (2)

16714-034-01 120 TABLET, FILM COATED in 1 BOTTLE (16714-034-01) 16714-034-02 500 TABLET, FILM COATED in 1 BOTTLE (16714-034-02)

Ingredients (1)

levetiracetam (250 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": "40911071-2280-bd37-e063-6394a90a0156", "openfda": {"nui": ["N0000008486"], "upc": ["0316714034010", "0316714035024", "0316714034027", "0316714537016", "0316714310015", "0316714035017", "0316714537023"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["3884cb76-822b-400d-9b24-49c286c9b6f7"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (16714-034-01)", "package_ndc": "16714-034-01", "marketing_start_date": "20220329"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16714-034-02)", "package_ndc": "16714-034-02", "marketing_start_date": "20220329"}], "brand_name": "Levetiracetam", "product_id": "16714-034_40911071-2280-bd37-e063-6394a90a0156", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "16714-034", "generic_name": "Levetiracetam", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "250 mg/1"}], "application_number": "ANDA090515", "marketing_category": "ANDA", "marketing_start_date": "20220329", "listing_expiration_date": "20261231"}