levetiracetam

Generic: levetiracetam

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7265
Product ID 0904-7265_0253fb34-3555-4f12-9442-0a9be7bb6878
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201157
Listing Expiration 2026-12-31
Marketing Start 2015-06-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047265
Hyphenated Format 0904-7265

Supplemental Identifiers

RxCUI
403884
UPC
0309047265411
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 ANDA201157 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 5 TRAY in 1 CASE (0904-7265-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)
  • 3 TRAY in 1 CASE (0904-7265-93) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)
  • 4 TRAY in 1 CASE (0904-7265-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)
source: ndc

Packages (3)

0904-7265-92 5 TRAY in 1 CASE (0904-7265-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41) 0904-7265-93 3 TRAY in 1 CASE (0904-7265-93) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41) 0904-7265-94 4 TRAY in 1 CASE (0904-7265-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)

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": "0253fb34-3555-4f12-9442-0a9be7bb6878", "openfda": {"nui": ["N0000008486"], "upc": ["0309047265411"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["423d2185-0931-4414-8864-7594000809ee"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 TRAY in 1 CASE (0904-7265-92)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)", "package_ndc": "0904-7265-92", "marketing_start_date": "20221121"}, {"sample": false, "description": "3 TRAY in 1 CASE (0904-7265-93)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)", "package_ndc": "0904-7265-93", "marketing_start_date": "20221121"}, {"sample": false, "description": "4 TRAY in 1 CASE (0904-7265-94)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41)", "package_ndc": "0904-7265-94", "marketing_start_date": "20221121"}], "brand_name": "Levetiracetam", "product_id": "0904-7265_0253fb34-3555-4f12-9442-0a9be7bb6878", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0904-7265", "generic_name": "LEVETIRACETAM", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA201157", "marketing_category": "ANDA", "marketing_start_date": "20150604", "listing_expiration_date": "20261231"}