levetiracetam

Generic: levetiracetam

Labeler: natco pharma usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler natco pharma usa llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-157
Product ID 69339-157_2ec94a03-8590-4617-a6e6-782e0aae7037
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203052
Listing Expiration 2026-12-31
Marketing Start 2021-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69339157
Hyphenated Format 69339-157

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 ANDA203052 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-17) / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05)
  • 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-19) / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05)
source: ndc

Packages (2)

69339-157-17 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-17) / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05) 69339-157-19 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-19) / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05)

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": "2ec94a03-8590-4617-a6e6-782e0aae7037", "openfda": {"nui": ["N0000008486"], "unii": ["44YRR34555"], "rxcui": ["403884"], "spl_set_id": ["34af3602-0188-4d2e-904b-2e40000bb45c"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-17)  / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05)", "package_ndc": "69339-157-17", "marketing_start_date": "20210131"}, {"sample": false, "description": "100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-19)  / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05)", "package_ndc": "69339-157-19", "marketing_start_date": "20210131"}], "brand_name": "Levetiracetam", "product_id": "69339-157_2ec94a03-8590-4617-a6e6-782e0aae7037", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69339-157", "generic_name": "Levetiracetam", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA203052", "marketing_category": "ANDA", "marketing_start_date": "20210131", "listing_expiration_date": "20261231"}