levetiracetam

Generic: levetiracetam

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levetiracetam 1000 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1901
Product ID 70518-1901_4987ad82-cd46-45b0-e063-6394a90af127
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090515
Listing Expiration 2027-12-31
Marketing Start 2019-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181901
Hyphenated Format 70518-1901

Supplemental Identifiers

RxCUI
387003
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 ANDA090515 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-1901-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1901-2)
source: ndc

Packages (1)

70518-1901-1 30 POUCH in 1 BOX (70518-1901-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1901-2)

Ingredients (1)

levetiracetam (1000 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": "4987ad82-cd46-45b0-e063-6394a90af127", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["387003"], "spl_set_id": ["ae405796-1eca-4890-bcb2-e1b07654a24d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-1901-1)  / 1 TABLET, FILM COATED in 1 POUCH (70518-1901-2)", "package_ndc": "70518-1901-1", "marketing_start_date": "20210804"}], "brand_name": "Levetiracetam", "product_id": "70518-1901_4987ad82-cd46-45b0-e063-6394a90af127", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-1901", "generic_name": "Levetiracetam", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "1000 mg/1"}], "application_number": "ANDA090515", "marketing_category": "ANDA", "marketing_start_date": "20190222", "listing_expiration_date": "20271231"}