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United States · US · US:0904-6792_9b081f9e-c042-4aa8-833a-0701015ab9a4

Modafinil

Orange BookUNIISPLATC N06BA07

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

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeN06BA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0904679204
    30 BLISTER PACK in 1 CARTON (0904-6792-04) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
R3UK8X3U3D
MODAFINIL
RxCUI 30125
Orange Book
A077667
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R3UK8X3U3D",
    "rxcui": "30125",
    "inchikey": "YFGHCGITMMYXAQ-UHFFFAOYSA-N",
    "display_name": "MODAFINIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1d4c6858-5b2f-f216-e063-6394a90aad5d": {
      "match": "brand_token",
      "title": "MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "3",
      "published_date": "2026-03-18"
    }
  },
  "productid": "0904-6792_9b081f9e-c042-4aa8-833a-0701015ab9a4",
  "productndc": "0904-6792",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077667",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 3, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Feb 3, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MODAFINIL",
  "proprietary_name": "Modafinil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077667",
  "marketing_category": "ANDA",
  "nonproprietary_name": "modafinil",
  "start_marketing_date": "20140203",
  "active_numerator_strength": "200"
}

Related drugs

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