levetiracetam

Generic: levetiracetam

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-117
Product ID 68180-117_8690e365-04d0-44ee-98ec-281e438ee0b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091399
Listing Expiration 2026-12-31
Marketing Start 2011-09-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180117
Hyphenated Format 68180-117

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 (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA091399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-07)
source: ndc

Packages (1)

68180-117-07 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-07)

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": "8690e365-04d0-44ee-98ec-281e438ee0b0", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378"], "spl_set_id": ["18648f51-a37c-41e1-b451-123bc0cf5446"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-07)", "package_ndc": "68180-117-07", "marketing_start_date": "20110912"}], "brand_name": "Levetiracetam", "product_id": "68180-117_8690e365-04d0-44ee-98ec-281e438ee0b0", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68180-117", "generic_name": "Levetiracetam", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA091399", "marketing_category": "ANDA", "marketing_start_date": "20110912", "listing_expiration_date": "20261231"}