levetiracetam

Generic: levetiracetam

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levetiracetam 100 mg/mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-313
Product ID 68094-313_3df07a98-b210-fcdd-e063-6294a90a066f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209781
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094313
Hyphenated Format 68094-313

Supplemental Identifiers

RxCUI
647121
UPC
0368094313254 0368094313100
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 (68094-313-10) / 5 mL in 1 VIAL, SINGLE-USE
  • 25 VIAL, SINGLE-USE in 1 CARTON (68094-313-25) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

68094-313-10 10 VIAL, SINGLE-USE in 1 CARTON (68094-313-10) / 5 mL in 1 VIAL, SINGLE-USE 68094-313-25 25 VIAL, SINGLE-USE in 1 CARTON (68094-313-25) / 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": "3df07a98-b210-fcdd-e063-6294a90a066f", "openfda": {"nui": ["N0000008486"], "upc": ["0368094313254", "0368094313100"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["6fb1e4d3-520c-44f1-a09d-d7b779e4edfd"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Precision Dose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (68094-313-10)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68094-313-10", "marketing_start_date": "20241010"}, {"sample": false, "description": "25 VIAL, SINGLE-USE in 1 CARTON (68094-313-25)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68094-313-25", "marketing_start_date": "20241010"}], "brand_name": "Levetiracetam", "product_id": "68094-313_3df07a98-b210-fcdd-e063-6294a90a066f", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68094-313", "generic_name": "levetiracetam", "labeler_name": "Precision Dose, 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": "20241010", "listing_expiration_date": "20261231"}