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United States · US · US:60429-001_3dd48c06-8784-6926-e063-6294a90a7590

Nuvigil

Orange BookUNIISPLATC N06BA13

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

Identification

ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeN06BA13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6042900130
    30 TABLET in 1 BOTTLE (60429-001-30)

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": {
    "3dd49302-f757-d945-e063-6294a90afcba": {
      "match": "brand_token",
      "title": "NUVIGIL (ARMODAFINIL) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "1",
      "published_date": "2025-09-05"
    }
  },
  "productid": "60429-001_3dd48c06-8784-6926-e063-6294a90a7590",
  "productndc": "60429-001",
  "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        "strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "Nuvigil",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021875",
  "marketing_category": "NDA",
  "nonproprietary_name": "Armodafinil",
  "start_marketing_date": "20070615",
  "active_numerator_strength": "50"
}

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