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 SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3803
Product ID 70518-3803_424d104e-76be-9c39-e063-6394a90a266b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079063
Listing Expiration 2026-12-31
Marketing Start 2023-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183803
Hyphenated Format 70518-3803

Supplemental Identifiers

RxCUI
403884
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 ANDA079063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 CUP, UNIT-DOSE in 1 BOX (70518-3803-0) / 7.5 mL in 1 CUP, UNIT-DOSE (70518-3803-1)
  • 10 CUP, UNIT-DOSE in 1 BOX (70518-3803-2) / 5 mL in 1 CUP, UNIT-DOSE (70518-3803-3)
  • 10 CUP, UNIT-DOSE in 1 BOX (70518-3803-4) / 12.5 mL in 1 CUP, UNIT-DOSE (70518-3803-5)
  • 10 CUP, UNIT-DOSE in 1 BOX (70518-3803-8) / 15 mL in 1 CUP, UNIT-DOSE (70518-3803-9)
source: ndc

Packages (4)

70518-3803-0 10 CUP, UNIT-DOSE in 1 BOX (70518-3803-0) / 7.5 mL in 1 CUP, UNIT-DOSE (70518-3803-1) 70518-3803-2 10 CUP, UNIT-DOSE in 1 BOX (70518-3803-2) / 5 mL in 1 CUP, UNIT-DOSE (70518-3803-3) 70518-3803-4 10 CUP, UNIT-DOSE in 1 BOX (70518-3803-4) / 12.5 mL in 1 CUP, UNIT-DOSE (70518-3803-5) 70518-3803-8 10 CUP, UNIT-DOSE in 1 BOX (70518-3803-8) / 15 mL in 1 CUP, UNIT-DOSE (70518-3803-9)

Ingredients (1)

levetiracetam (100 mg/mL)

Linked Drug Pages (1)

Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "424d104e-76be-9c39-e063-6394a90a266b", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["94d042f7-93b9-43bd-9ace-cfc61903b4d7"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 BOX (70518-3803-0)  / 7.5 mL in 1 CUP, UNIT-DOSE (70518-3803-1)", "package_ndc": "70518-3803-0", "marketing_start_date": "20230724"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 BOX (70518-3803-2)  / 5 mL in 1 CUP, UNIT-DOSE (70518-3803-3)", "package_ndc": "70518-3803-2", "marketing_start_date": "20230724"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 BOX (70518-3803-4)  / 12.5 mL in 1 CUP, UNIT-DOSE (70518-3803-5)", "package_ndc": "70518-3803-4", "marketing_start_date": "20230724"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 BOX (70518-3803-8)  / 15 mL in 1 CUP, UNIT-DOSE (70518-3803-9)", "package_ndc": "70518-3803-8", "marketing_start_date": "20230724"}], "brand_name": "Levetiracetam", "product_id": "70518-3803_424d104e-76be-9c39-e063-6394a90a266b", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-3803", "generic_name": "Levetiracetam", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA079063", "marketing_category": "ANDA", "marketing_start_date": "20230724", "listing_expiration_date": "20261231"}