levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler civica, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-360
Product ID 72572-360_2688af36-2f4b-499d-95a4-380f2e0d9787
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090981
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72572360
Hyphenated Format 72572-360

Supplemental Identifiers

RxCUI
647121
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 ANDA090981 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (72572-360-25) / 5 mL in 1 VIAL (72572-360-01)
source: ndc

Packages (1)

72572-360-25 25 VIAL in 1 CARTON (72572-360-25) / 5 mL in 1 VIAL (72572-360-01)

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": ["INTRAVENOUS"], "spl_id": "2688af36-2f4b-499d-95a4-380f2e0d9787", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["1591c690-f4ed-44b7-a9d0-bff1fbb4bfef"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (72572-360-25)  / 5 mL in 1 VIAL (72572-360-01)", "package_ndc": "72572-360-25", "marketing_start_date": "20221201"}], "brand_name": "Levetiracetam", "product_id": "72572-360_2688af36-2f4b-499d-95a4-380f2e0d9787", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72572-360", "generic_name": "Levetiracetam", "labeler_name": "Civica, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA090981", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}