roweepra

Generic: levetiracetam

Labeler: owp pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name roweepra
Generic Name levetiracetam
Labeler owp pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levetiracetam 250 mg/1

Manufacturer
OWP Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 69102-108
Product ID 69102-108_c7262ce0-c186-487b-9808-b340d31d8fe4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078858
Listing Expiration 2026-12-31
Marketing Start 2020-10-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69102108
Hyphenated Format 69102-108

Supplemental Identifiers

RxCUI
311288 311289 311290 387003 1875868
UPC
0369102107018 0369102106011
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 roweepra (source: ndc)
Generic Name levetiracetam (source: ndc)
Application Number ANDA078858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (69102-108-01)
source: ndc

Packages (1)

69102-108-01 120 TABLET in 1 BOTTLE (69102-108-01)

Ingredients (1)

levetiracetam (250 mg/1)

Linked Drug Pages (1)

Levetiracetam, Roweepra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c7262ce0-c186-487b-9808-b340d31d8fe4", "openfda": {"nui": ["N0000008486"], "upc": ["0369102107018", "0369102106011"], "unii": ["44YRR34555"], "rxcui": ["311288", "311289", "311290", "387003", "1875868"], "spl_set_id": ["e662bf5b-c81c-4bcd-ba2e-552df95ca6f9"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["OWP Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (69102-108-01)", "package_ndc": "69102-108-01", "marketing_start_date": "20201028"}], "brand_name": "Roweepra", "product_id": "69102-108_c7262ce0-c186-487b-9808-b340d31d8fe4", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69102-108", "generic_name": "Levetiracetam", "labeler_name": "OWP Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Roweepra", "active_ingredients": [{"name": "LEVETIRACETAM", "strength": "250 mg/1"}], "application_number": "ANDA078858", "marketing_category": "ANDA", "marketing_start_date": "20201028", "listing_expiration_date": "20261231"}