elepsia xr 1500 mg

Generic: levetiracetam

Labeler: tripoint therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name elepsia xr 1500 mg
Generic Name levetiracetam
Labeler tripoint therapeutics, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levetiracetam 1500 mg/1

Manufacturer
TRIPOINT THERAPEUTICS, LLC

Identifiers & Regulatory

Product NDC 80705-101
Product ID 80705-101_3c463bee-1191-4cab-b4d0-367673db19ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204417
Listing Expiration 2026-12-31
Marketing Start 2021-02-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80705101
Hyphenated Format 80705-101

Supplemental Identifiers

RxCUI
1605362 1605368 1605372 1605374
UPC
0380705101302 0380705100305
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 elepsia xr 1500 mg (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number NDA204417 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1500 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (80705-101-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30)
  • 1 BLISTER PACK in 1 CARTON (80705-101-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

80705-101-02 1 BLISTER PACK in 1 CARTON (80705-101-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 80705-101-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30) 80705-101-99 1 BLISTER PACK in 1 CARTON (80705-101-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

levetiracetam (1500 mg/1)

Linked Drug Pages (1)

ELEPSIA XR 1000 MG, ELEPSIA XR 1500 MG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3c463bee-1191-4cab-b4d0-367673db19ef", "openfda": {"nui": ["N0000008486"], "upc": ["0380705101302", "0380705100305"], "unii": ["44YRR34555"], "rxcui": ["1605362", "1605368", "1605372", "1605374"], "spl_set_id": ["cac83d47-88a2-4447-a0c0-90b44ffda0ac"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["TRIPOINT THERAPEUTICS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (80705-101-02)  / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "80705-101-02", "marketing_start_date": "20210929"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30)", "package_ndc": "80705-101-30", "marketing_start_date": "20210212"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (80705-101-99)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "80705-101-99", "marketing_start_date": "20210212"}], "brand_name": "ELEPSIA XR 1500 MG", "product_id": "80705-101_3c463bee-1191-4cab-b4d0-367673db19ef", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "80705-101", "generic_name": "levetiracetam", "labeler_name": "TRIPOINT THERAPEUTICS, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELEPSIA XR 1500 MG", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "1500 mg/1"}], "application_number": "NDA204417", "marketing_category": "NDA", "marketing_start_date": "20210212", "listing_expiration_date": "20261231"}