Armodafinil

Orange BookUNIISPLATC N06BA13

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

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeN06BA13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218946430
30 TABLET in 1 BOTTLE (72189-464-30)

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": "72189-464_2c4dd8aa-05cd-69f7-e063-6294a90abcd1",
  "productndc": "72189-464",
  "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": "20230503",
  "active_numerator_strength": "50"
}

Related drugs

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