brivaracetam

Orange BookUNIISPLATC N03AX23

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN03AX23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7071015844
100 BLISTER PACK in 1 CARTON (70710-1584-4) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70710-1584-7)
ndc11
7071015846
60 TABLET, FILM COATED in 1 BOTTLE (70710-1584-6)
ndc11
7071015848
180 TABLET, FILM COATED in 1 BOTTLE (70710-1584-8)

Annotations

UNII (FDA Substance ID)

U863JGG2IA

BRIVARACETAM

RxCUI 1739745

Orange Book

A214501

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": "70710-1584_dd7c5f3e-5cd5-4219-bf1a-7fe15b291998",
  "productndc": "70710-1584",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214501",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Oct 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Oct 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Oct 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Oct 3, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIVARACETAM",
  "proprietary_name": "brivaracetam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214501",
  "marketing_category": "ANDA",
  "nonproprietary_name": "brivaracetam",
  "start_marketing_date": "20260221",
  "active_numerator_strength": "10"
}

Related drugs

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