levetiracetam

Generic: levetiracetam

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler solco healthcare us, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 500 mg/5mL

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-454
Product ID 43547-454_2528785e-b8b2-4e7a-9787-54766f62c6bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209474
Listing Expiration 2026-12-31
Marketing Start 2022-04-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547454
Hyphenated Format 43547-454

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 ANDA209474 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (43547-454-10) / 5 mL in 1 VIAL, SINGLE-DOSE (43547-454-41)
source: ndc

Packages (1)

43547-454-10 10 VIAL, SINGLE-DOSE in 1 CARTON (43547-454-10) / 5 mL in 1 VIAL, SINGLE-DOSE (43547-454-41)

Ingredients (1)

levetiracetam (500 mg/5mL)

Linked Drug Pages (1)

LEVETIRACETAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2528785e-b8b2-4e7a-9787-54766f62c6bb", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["cfe618ae-f7de-43d8-a754-3ce0a08c48ee"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (43547-454-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (43547-454-41)", "package_ndc": "43547-454-10", "marketing_start_date": "20220411"}], "brand_name": "LEVETIRACETAM", "product_id": "43547-454_2528785e-b8b2-4e7a-9787-54766f62c6bb", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "43547-454", "generic_name": "levetiracetam", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/5mL"}], "application_number": "ANDA209474", "marketing_category": "ANDA", "marketing_start_date": "20220411", "listing_expiration_date": "20261231"}