levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler patrin pharma, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Patrin Pharma, Inc.

Identifiers & Regulatory

Product NDC 39328-511
Product ID 39328-511_6e8da622-1edb-4ca7-8b48-b77d580246e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078582
Listing Expiration 2026-12-31
Marketing Start 2024-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 39328511
Hyphenated Format 39328-511

Supplemental Identifiers

RxCUI
403884
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 ANDA078582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 5 mL in 1 CUP, UNIT-DOSE (39328-511-05)
  • 3 TRAY in 1 CASE (39328-511-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
  • 4 TRAY in 1 CASE (39328-511-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
  • 5 TRAY in 1 CASE (39328-511-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (4)

39328-511-05 5 mL in 1 CUP, UNIT-DOSE (39328-511-05) 39328-511-30 3 TRAY in 1 CASE (39328-511-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 39328-511-40 4 TRAY in 1 CASE (39328-511-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 39328-511-50 5 TRAY in 1 CASE (39328-511-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE

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": "6e8da622-1edb-4ca7-8b48-b77d580246e1", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["49117cee-a96c-4593-91a7-8a133e3f0939"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Patrin Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 CUP, UNIT-DOSE (39328-511-05)", "package_ndc": "39328-511-05", "marketing_start_date": "20240131"}, {"sample": false, "description": "3 TRAY in 1 CASE (39328-511-30)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "39328-511-30", "marketing_start_date": "20240131"}, {"sample": false, "description": "4 TRAY in 1 CASE (39328-511-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "39328-511-40", "marketing_start_date": "20240131"}, {"sample": false, "description": "5 TRAY in 1 CASE (39328-511-50)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "39328-511-50", "marketing_start_date": "20240131"}], "brand_name": "Levetiracetam", "product_id": "39328-511_6e8da622-1edb-4ca7-8b48-b77d580246e1", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "39328-511", "generic_name": "Levetiracetam", "labeler_name": "Patrin Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA078582", "marketing_category": "ANDA", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}