brivaracetam

Orange BookUNIISPLATC N03AX23

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC

CountryUS (United States)

ATC codeN03AX23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7220526806
100 BLISTER PACK in 1 CARTON (72205-268-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7220526860
60 TABLET, FILM COATED in 1 BOTTLE (72205-268-60)

Annotations

UNII (FDA Substance ID)

U863JGG2IA

BRIVARACETAM

RxCUI 1739745

Orange Book

A214921

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "U863JGG2IA",
    "rxcui": "1739745",
    "inchikey": "MSYKRHVOOPPJKU-BDAKNGLRSA-N",
    "display_name": "BRIVARACETAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5115c5b4-7a23-89f2-e063-6294a90a222a": {
      "match": "brand_token",
      "title": "BRIVARACETAM TABLET, FILM COATED [AVKARE]",
      "spl_version": "1",
      "published_date": "2026-05-11"
    }
  },
  "productid": "72205-268_11ca0e1d-1c0d-4357-9ebd-ee1e87185dde",
  "productndc": "72205-268",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214921",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Nov 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Nov 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Nov 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Nov 13, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIVARACETAM",
  "proprietary_name": "brivaracetam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214921",
  "marketing_category": "ANDA",
  "nonproprietary_name": "brivaracetam",
  "start_marketing_date": "20251113",
  "active_numerator_strength": "25"
}

Related drugs

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