levetiracetam

Generic: levetiracetam

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-617
Product ID 43063-617_3ed985b7-4a9b-fcf3-e063-6294a90ac0b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078154
Listing Expiration 2026-12-31
Marketing Start 2009-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063617
Hyphenated Format 43063-617

Supplemental Identifiers

RxCUI
311289
UPC
0343063617601
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 (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA078154 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-617-60)
source: ndc

Packages (1)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3ed985b7-4a9b-fcf3-e063-6294a90ac0b9", "openfda": {"nui": ["N0000008486"], "upc": ["0343063617601"], "unii": ["44YRR34555"], "rxcui": ["311289"], "spl_set_id": ["c4b2da6a-ed50-4a54-90bd-32f76b178736"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-617-60)", "package_ndc": "43063-617-60", "marketing_start_date": "20150801"}], "brand_name": "Levetiracetam", "product_id": "43063-617_3ed985b7-4a9b-fcf3-e063-6294a90ac0b9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "43063-617", "generic_name": "Levetiracetam", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA078154", "marketing_category": "ANDA", "marketing_start_date": "20090115", "listing_expiration_date": "20261231"}