levetiracetam

Generic: levetiracetam

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-769
Product ID 67877-769_40d1180e-73b5-4e73-8d42-15b99313496f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216375
Listing Expiration 2026-12-31
Marketing Start 2022-05-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877769
Hyphenated Format 67877-769

Supplemental Identifiers

RxCUI
311288 311289 311290 387003
UPC
0367877771601 0367877769127 0367877771335 0367877768304 0367877770055
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 ANDA216375 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-769-05)
  • 120 TABLET, FILM COATED in 1 BOTTLE (67877-769-12)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-769-30)
  • 1 BLISTER PACK in 1 CARTON (67877-769-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (67877-769-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (5)

67877-769-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-769-05) 67877-769-12 120 TABLET, FILM COATED in 1 BOTTLE (67877-769-12) 67877-769-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-769-30) 67877-769-33 1 BLISTER PACK in 1 CARTON (67877-769-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK 67877-769-38 10 BLISTER PACK in 1 CARTON (67877-769-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "40d1180e-73b5-4e73-8d42-15b99313496f", "openfda": {"nui": ["N0000008486"], "upc": ["0367877771601", "0367877769127", "0367877771335", "0367877768304", "0367877770055"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003"], "spl_set_id": ["591dd9f1-3681-4b2f-b096-7536826e3648"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-769-05)", "package_ndc": "67877-769-05", "marketing_start_date": "20220528"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (67877-769-12)", "package_ndc": "67877-769-12", "marketing_start_date": "20220528"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-769-30)", "package_ndc": "67877-769-30", "marketing_start_date": "20220528"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-769-33)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-769-33", "marketing_start_date": "20220528"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-769-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-769-38", "marketing_start_date": "20241029"}], "brand_name": "Levetiracetam", "product_id": "67877-769_40d1180e-73b5-4e73-8d42-15b99313496f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67877-769", "generic_name": "Levetiracetam", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA216375", "marketing_category": "ANDA", "marketing_start_date": "20220528", "listing_expiration_date": "20261231"}