levetiracetam

Generic: levetiracetam

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-788
Product ID 16571-788_c6ae1c97-1923-4afe-b409-89c41de30e60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078993
Marketing Start 2009-01-15
Marketing End 2026-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571788
Hyphenated Format 16571-788

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
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 ANDA078993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (16571-788-50)
source: ndc

Packages (1)

16571-788-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-788-50)

Ingredients (1)

levetiracetam (500 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": "c6ae1c97-1923-4afe-b409-89c41de30e60", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["d2f5416c-631d-48cc-a6ce-f998c7217d70"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16571-788-50)", "package_ndc": "16571-788-50", "marketing_end_date": "20260331", "marketing_start_date": "20090115"}], "brand_name": "Levetiracetam", "product_id": "16571-788_c6ae1c97-1923-4afe-b409-89c41de30e60", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "16571-788", "generic_name": "Levetiracetam", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA078993", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20090115"}