Back to search
🇺🇸

United States · US · US:0781-8037_dea0ad34-a35f-42ba-a6b6-dea58a16868f

Armodafinil

Orange BookUNIISPLATC N06BA13

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeN06BA13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0781803731
    30 TABLET in 1 BOTTLE (0781-8037-31)

Annotations

UNII (FDA Substance ID)
V63XWA605I
ARMODAFINIL
RxCUI 641465
Orange Book
N021875
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V63XWA605I",
    "rxcui": "641465",
    "inchikey": "YFGHCGITMMYXAQ-LJQANCHMSA-N",
    "display_name": "ARMODAFINIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4128759d-ed7c-4130-b24c-a0541f2b9e7f": {
      "match": "brand_token",
      "title": "ARMODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "6",
      "published_date": "2026-03-09"
    }
  },
  "productid": "0781-8037_dea0ad34-a35f-42ba-a6b6-dea58a16868f",
  "productndc": "0781-8037",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021875",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 15, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Mar 26, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jun 15, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "004",
        "approval_date": "Jun 15, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Mar 26, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARMODAFINIL",
  "proprietary_name": "Armodafinil",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021875",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Armodafinil",
  "start_marketing_date": "20161201",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code N06BA13.

Access this data programmatically

Query Armodafinil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.