levetiracetam

Generic: levetiracetam

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler micro labs limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levetiracetam 100 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-331
Product ID 42571-331_1ccd66c0-e671-efb8-e063-6394a90aed04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211954
Listing Expiration 2026-12-31
Marketing Start 2019-10-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571331
Hyphenated Format 42571-331

Supplemental Identifiers

RxCUI
647121
UPC
0342571331924
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 ANDA211954 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (42571-331-92) / 5 mL in 1 VIAL
source: ndc

Packages (1)

42571-331-92 10 VIAL in 1 CARTON (42571-331-92) / 5 mL in 1 VIAL

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": "1ccd66c0-e671-efb8-e063-6394a90aed04", "openfda": {"nui": ["N0000008486"], "upc": ["0342571331924"], "unii": ["44YRR34555"], "rxcui": ["647121"], "spl_set_id": ["1e3cfafe-5784-4ec6-91dc-cd74b01d0bb4"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (42571-331-92)  / 5 mL in 1 VIAL", "package_ndc": "42571-331-92", "marketing_start_date": "20191004"}], "brand_name": "LEVETIRACETAM", "product_id": "42571-331_1ccd66c0-e671-efb8-e063-6394a90aed04", "dosage_form": "INJECTION", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "42571-331", "generic_name": "LEVETIRACETAM", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "100 mg/mL"}], "application_number": "ANDA211954", "marketing_category": "ANDA", "marketing_start_date": "20191004", "listing_expiration_date": "20261231"}