levetiracetam

Generic: levetiracetam

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 15 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-154
Product ID 68083-154_446e0964-1e66-48ae-8065-da9c88662828
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206880
Listing Expiration 2026-12-31
Marketing Start 2017-11-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083154
Hyphenated Format 68083-154

Supplemental Identifiers

RxCUI
1193358 1193360 1193362
UPC
0368083153014
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
  • 15 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (68083-154-10) / 100 mL in 1 BAG (68083-154-01)
source: ndc

Packages (1)

68083-154-10 10 BAG in 1 CARTON (68083-154-10) / 100 mL in 1 BAG (68083-154-01)

Ingredients (1)

levetiracetam (15 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": "446e0964-1e66-48ae-8065-da9c88662828", "openfda": {"nui": ["N0000008486"], "upc": ["0368083153014"], "unii": ["44YRR34555"], "rxcui": ["1193358", "1193360", "1193362"], "spl_set_id": ["aa883d9c-c6cd-44ab-a1de-058985e4f97f"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (68083-154-10)  / 100 mL in 1 BAG (68083-154-01)", "package_ndc": "68083-154-10", "marketing_start_date": "20171107"}], "brand_name": "Levetiracetam", "product_id": "68083-154_446e0964-1e66-48ae-8065-da9c88662828", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68083-154", "generic_name": "Levetiracetam", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "15 mg/mL"}], "application_number": "ANDA206880", "marketing_category": "ANDA", "marketing_start_date": "20171107", "listing_expiration_date": "20261231"}