Armodafinil

Orange BookUNIISPLATC N06BA13

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

Identification

ManufacturerNatco Pharma USA LLC

CountryUS (United States)

ATC codeN06BA13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6933918003
30 TABLET in 1 BOTTLE (69339-180-03)
ndc11
6933918005
500 TABLET in 1 BOTTLE (69339-180-05)

Annotations

UNII (FDA Substance ID)

V63XWA605I

ARMODAFINIL

RxCUI 641465

Orange Book

A202768

ABABABABAB

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": "69339-180_d93dca81-a0da-49ee-be61-86e713ab56cd",
  "productndc": "69339-180",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202768",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "003",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Sep 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Sep 28, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARMODAFINIL",
  "proprietary_name": "Armodafinil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202768",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Armodafinil",
  "start_marketing_date": "20230323",
  "active_numerator_strength": "250"
}

Related drugs

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