levetiracetam

Generic: levetiracetam

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

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler tagi pharma, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
TAGI Pharma, Inc.

Identifiers & Regulatory

Product NDC 51224-013
Product ID 51224-013_42cf4e4e-931e-8c30-e063-6394a90a9cb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209781
Listing Expiration 2026-12-31
Marketing Start 2018-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51224013
Hyphenated Format 51224-013

Supplemental Identifiers

RxCUI
647121
UPC
0351224013100
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 ANDA209781 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (51224-013-10) / 5 mL in 1 VIAL, SINGLE-USE
  • 25 VIAL, SINGLE-USE in 1 CARTON (51224-013-25) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

51224-013-10 10 VIAL, SINGLE-USE in 1 CARTON (51224-013-10) / 5 mL in 1 VIAL, SINGLE-USE 51224-013-25 25 VIAL, SINGLE-USE in 1 CARTON (51224-013-25) / 5 mL in 1 VIAL, SINGLE-USE

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": ["INTRAVENOUS"], "spl_id": "42cf4e4e-931e-8c30-e063-6394a90a9cb6", "openfda": {"nui": ["N0000008486"], "upc": ["0351224013100"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["TAGI Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (51224-013-10)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "51224-013-10", "marketing_end_date": "20260810", "marketing_start_date": "20181130"}, {"sample": false, "description": "25 VIAL, SINGLE-USE in 1 CARTON (51224-013-25)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "51224-013-25", "marketing_end_date": "20260811", "marketing_start_date": "20181130"}], "brand_name": "Levetiracetam", "product_id": "51224-013_42cf4e4e-931e-8c30-e063-6394a90a9cb6", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "51224-013", "generic_name": "levetiracetam", "labeler_name": "TAGI Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levetiracetam", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA209781", "marketing_category": "ANDA", "marketing_start_date": "20181130", "listing_expiration_date": "20261231"}