levetiracetam er

Generic: levetiracetam

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

Drug Facts

Product Profile

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

levetiracetam 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4125
Product ID 70518-4125_3c5503f0-b200-3733-e063-6394a90a0ec9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205130
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184125
Hyphenated Format 70518-4125

Supplemental Identifiers

RxCUI
807832
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
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4125-0)
source: ndc

Packages (1)

70518-4125-0 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4125-0)

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": "3c5503f0-b200-3733-e063-6394a90a0ec9", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["807832"], "spl_set_id": ["2d57f22f-fecc-466e-a444-87708c7c2f80"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4125-0)", "package_ndc": "70518-4125-0", "marketing_start_date": "20240701"}], "brand_name": "Levetiracetam ER", "product_id": "70518-4125_3c5503f0-b200-3733-e063-6394a90a0ec9", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-4125", "generic_name": "Levetiracetam", "labeler_name": "REMEDYREPACK INC.", "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": "20240701", "listing_expiration_date": "20261231"}