Roweepra

Orange BookUNIISPLATC N03AX14

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOWP Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN03AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6910210801
120 TABLET in 1 BOTTLE (69102-108-01)

Annotations

UNII (FDA Substance ID)

44YRR34555

LEVETIRACETAM

RxCUI 114477

Orange Book

A078858

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "44YRR34555",
    "rxcui": "114477",
    "inchikey": "HPHUVLMMVZITSG-LURJTMIESA-N",
    "display_name": "LEVETIRACETAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e662bf5b-c81c-4bcd-ba2e-552df95ca6f9": {
      "match": "brand_token",
      "title": "ROWEEPRA (LEVETIRACETAM) TABLET LEVETIRACETAM TABLET [OWP PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2025-05-26"
    }
  },
  "productid": "69102-108_c7262ce0-c186-487b-9808-b340d31d8fe4",
  "productndc": "69102-108",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078858",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jan 15, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jan 15, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "003",
        "approval_date": "Jan 15, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "004",
        "approval_date": "Jan 15, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Roweepra",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078858",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levetiracetam",
  "start_marketing_date": "20201028",
  "active_numerator_strength": "250"
}

Related drugs

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