levetiracetam

Generic: levetiracetam

Labeler: method pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler method pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 500 mg/5mL

Manufacturer
Method Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 58657-860
Product ID 58657-860_47cfd9a6-663a-7cc6-e063-6294a90a4666
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209781
Listing Expiration 2027-12-31
Marketing Start 2025-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58657860
Hyphenated Format 58657-860

Supplemental Identifiers

RxCUI
647121
UPC
0358657860004
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
  • 500 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-01) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)
source: ndc

Packages (3)

58657-860-01 1 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-01) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) 58657-860-10 10 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00) 58657-860-25 25 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)

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": ["INTRAVENOUS"], "spl_id": "47cfd9a6-663a-7cc6-e063-6294a90a4666", "openfda": {"nui": ["N0000008486"], "upc": ["0358657860004"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["47cfe577-b4cb-d35e-e063-6394a90ad8c4"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Method Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-01)  / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)", "package_ndc": "58657-860-01", "marketing_start_date": "20251215"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)", "package_ndc": "58657-860-10", "marketing_start_date": "20251215"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25)  / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)", "package_ndc": "58657-860-25", "marketing_start_date": "20251215"}], "brand_name": "LEVETIRACETAM", "product_id": "58657-860_47cfd9a6-663a-7cc6-e063-6294a90a4666", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "58657-860", "generic_name": "levetiracetam", "labeler_name": "Method Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "500 mg/5mL"}], "application_number": "ANDA209781", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20271231"}