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United States · US · US:68788-7880_da87ba1c-5887-4492-8ae9-40a027d5e449

Armodafinil

Orange BookUNIISPLATC N06BA13

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

Identification

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

Packs · 3

  • ndc11
    6878878803
    30 TABLET in 1 BOTTLE (68788-7880-3)
  • ndc11
    6878878806
    60 TABLET in 1 BOTTLE (68788-7880-6)
  • ndc11
    6878878809
    90 TABLET in 1 BOTTLE (68788-7880-9)

Annotations

UNII (FDA Substance ID)
V63XWA605I
ARMODAFINIL
RxCUI 641465
Orange Book
A206069
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": "68788-7880_da87ba1c-5887-4492-8ae9-40a027d5e449",
  "productndc": "68788-7880",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206069",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 6, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Mar 6, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "003",
        "approval_date": "Mar 6, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Dec 7, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARMODAFINIL",
  "proprietary_name": "Armodafinil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206069",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Armodafinil",
  "start_marketing_date": "20210308",
  "active_numerator_strength": "150"
}

Related drugs

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