levetiracetam

Generic: levetiracetam

Labeler: athenex pharmaceutical division, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler athenex pharmaceutical division, llc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 10 mg/mL

Manufacturer
Athenex Pharmaceutical Division, LLC.

Identifiers & Regulatory

Product NDC 70860-603
Product ID 70860-603_34f97a49-2654-18d1-e063-6394a90acaff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206880
Marketing Start 2018-05-30
Marketing End 2026-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70860603
Hyphenated Format 70860-603

Supplemental Identifiers

RxCUI
1193358 1193360 1193362
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 ANDA206880 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (70860-603-82) / 1 BAG in 1 POUCH (70860-603-41) / 100 mL in 1 BAG
source: ndc

Packages (1)

70860-603-82 10 POUCH in 1 CARTON (70860-603-82) / 1 BAG in 1 POUCH (70860-603-41) / 100 mL in 1 BAG

Ingredients (1)

levetiracetam (10 mg/mL)

Linked Drug Pages (1)

Levetiracetam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "34f97a49-2654-18d1-e063-6394a90acaff", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["1193358", "1193360", "1193362"], "spl_set_id": ["da023a3c-e4c7-49a3-968e-9ae33ea7feda"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Athenex Pharmaceutical Division, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (70860-603-82)  / 1 BAG in 1 POUCH (70860-603-41)  / 100 mL in 1 BAG", "package_ndc": "70860-603-82", "marketing_end_date": "20260331", "marketing_start_date": "20180530"}], "brand_name": "Levetiracetam", "product_id": "70860-603_34f97a49-2654-18d1-e063-6394a90acaff", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70860-603", "generic_name": "Levetiracetam", "labeler_name": "Athenex Pharmaceutical Division, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "10 mg/mL"}], "application_number": "ANDA206880", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20180530"}