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, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 250 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-112
Product ID 68180-112_28bc73b1-951f-459b-83ec-57aae9aafdda
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 68180112
Hyphenated Format 68180-112

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 ANDA078154 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (68180-112-02)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68180-112-09)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68180-112-16)
source: ndc

Packages (3)

68180-112-02 500 TABLET, FILM COATED in 1 BOTTLE (68180-112-02) 68180-112-09 90 TABLET, FILM COATED in 1 BOTTLE (68180-112-09) 68180-112-16 120 TABLET, FILM COATED in 1 BOTTLE (68180-112-16)

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": "28bc73b1-951f-459b-83ec-57aae9aafdda", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["df661166-325d-4071-9bc1-f7bf992996d2"], "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": "500 TABLET, FILM COATED in 1 BOTTLE (68180-112-02)", "package_ndc": "68180-112-02", "marketing_start_date": "20090115"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68180-112-09)", "package_ndc": "68180-112-09", "marketing_start_date": "20090115"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68180-112-16)", "package_ndc": "68180-112-16", "marketing_start_date": "20090115"}], "brand_name": "Levetiracetam", "product_id": "68180-112_28bc73b1-951f-459b-83ec-57aae9aafdda", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68180-112", "generic_name": "Levetiracetam", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "250 mg/1"}], "application_number": "ANDA078154", "marketing_category": "ANDA", "marketing_start_date": "20090115", "listing_expiration_date": "20261231"}