levetiracetam er

Generic: levetiracetam

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam er
Generic Name levetiracetam
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-880
Product ID 71205-880_cb0d9a15-fb02-4393-bdf7-a88dc4b42d6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205130
Listing Expiration 2026-12-31
Marketing Start 2021-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205880
Hyphenated Format 71205-880

Supplemental Identifiers

RxCUI
807832 846378
UPC
0371205881306
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 er (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA205130 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-00)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-11)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-30)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-55)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-60)
  • 240 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-64)
  • 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-72)
  • 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-78)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-90)
source: ndc

Packages (9)

71205-880-00 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-00) 71205-880-11 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-11) 71205-880-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-30) 71205-880-55 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-55) 71205-880-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-60) 71205-880-64 240 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-64) 71205-880-72 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-72) 71205-880-78 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-78) 71205-880-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-90)

Ingredients (1)

levetiracetam (500 mg/1)

Linked Drug Pages (1)

Levetiracetam ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cb0d9a15-fb02-4393-bdf7-a88dc4b42d6a", "openfda": {"nui": ["N0000008486"], "upc": ["0371205881306"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378"], "spl_set_id": ["57b9dccb-6ee6-4e89-ab26-4c478e2df2b5"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-00)", "package_ndc": "71205-880-00", "marketing_start_date": "20211105"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-11)", "package_ndc": "71205-880-11", "marketing_start_date": "20211105"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-30)", "package_ndc": "71205-880-30", "marketing_start_date": "20211105"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-55)", "package_ndc": "71205-880-55", "marketing_start_date": "20211105"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-60)", "package_ndc": "71205-880-60", "marketing_start_date": "20211105"}, {"sample": false, "description": "240 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-64)", "package_ndc": "71205-880-64", "marketing_start_date": "20211105"}, {"sample": false, "description": "120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-72)", "package_ndc": "71205-880-72", "marketing_start_date": "20211105"}, {"sample": false, "description": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-78)", "package_ndc": "71205-880-78", "marketing_start_date": "20211105"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-880-90)", "package_ndc": "71205-880-90", "marketing_start_date": "20211105"}], "brand_name": "Levetiracetam ER", "product_id": "71205-880_cb0d9a15-fb02-4393-bdf7-a88dc4b42d6a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71205-880", "generic_name": "Levetiracetam", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "brand_name_suffix": "ER", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/1"}], "application_number": "ANDA205130", "marketing_category": "ANDA", "marketing_start_date": "20210930", "listing_expiration_date": "20261231"}