levetiracetam

Generic: levetiracetam

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levetiracetam
Generic Name levetiracetam
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 750 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-300
Product ID 13668-300_57f6fede-6470-4394-9136-bec266dfdf2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091338
Listing Expiration 2027-12-31
Marketing Start 2026-01-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668300
Hyphenated Format 13668-300

Supplemental Identifiers

RxCUI
807832 846378
UPC
0313668272055 0313668300055
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 ANDA091338 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-05)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-12)
  • 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-25)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-60)
source: ndc

Packages (4)

13668-300-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-05) 13668-300-12 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-12) 13668-300-25 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-25) 13668-300-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-60)

Ingredients (1)

levetiracetam (750 mg/1)

Linked Drug Pages (1)

LEVETIRACETAM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "57f6fede-6470-4394-9136-bec266dfdf2d", "openfda": {"nui": ["N0000008486"], "upc": ["0313668272055", "0313668300055"], "unii": ["44YRR34555"], "rxcui": ["807832", "846378"], "spl_set_id": ["7cb669d7-d1aa-43b3-a322-0a2eaa13c656"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-05)", "package_ndc": "13668-300-05", "marketing_start_date": "20260130"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-12)", "package_ndc": "13668-300-12", "marketing_start_date": "20260130"}, {"sample": false, "description": "250 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-25)", "package_ndc": "13668-300-25", "marketing_start_date": "20260130"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-60)", "package_ndc": "13668-300-60", "marketing_start_date": "20260130"}], "brand_name": "LEVETIRACETAM", "product_id": "13668-300_57f6fede-6470-4394-9136-bec266dfdf2d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "13668-300", "generic_name": "LEVETIRACETAM", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVETIRACETAM", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "750 mg/1"}], "application_number": "ANDA091338", "marketing_category": "ANDA", "marketing_start_date": "20260130", "listing_expiration_date": "20271231"}