levetiracetam

Generic: levetiracetam

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 500 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-4799
Product ID 0121-4799_f63f4202-d0c1-4ef3-8dc5-8bb4cab6a613
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 01214799
Hyphenated Format 0121-4799

Supplemental Identifiers

RxCUI
403884
UPC
0301210799167
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
  • 500 mg/5mL
source: ndc
Packaging
  • 4 TRAY in 1 CASE (0121-4799-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05)
  • 5 TRAY in 1 CASE (0121-4799-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05)
source: ndc

Packages (2)

0121-4799-40 4 TRAY in 1 CASE (0121-4799-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05) 0121-4799-50 5 TRAY in 1 CASE (0121-4799-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05)

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": ["ORAL"], "spl_id": "f63f4202-d0c1-4ef3-8dc5-8bb4cab6a613", "openfda": {"nui": ["N0000008486"], "upc": ["0301210799167"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["9dca1330-52ca-47a4-a134-ec55c9d5786d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TRAY in 1 CASE (0121-4799-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05)", "package_ndc": "0121-4799-40", "marketing_start_date": "20150604"}, {"sample": false, "description": "5 TRAY in 1 CASE (0121-4799-50)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05)", "package_ndc": "0121-4799-50", "marketing_start_date": "20200528"}], "brand_name": "Levetiracetam", "product_id": "0121-4799_f63f4202-d0c1-4ef3-8dc5-8bb4cab6a613", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0121-4799", "generic_name": "LEVETIRACETAM", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/5mL"}], "application_number": "ANDA201157", "marketing_category": "ANDA", "marketing_start_date": "20150604", "listing_expiration_date": "20261231"}