Armodafinil

Orange BookUNIISPLATC N06BA13

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06BA13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378343293
30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93)

Annotations

UNII (FDA Substance ID)

V63XWA605I

ARMODAFINIL

RxCUI 641465

Orange Book

A200043

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": "0378-3432_34fcca9f-37ba-40d9-9032-6ffeeb031a36",
  "productndc": "0378-3432",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "200043",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 1, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Jun 1, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "003",
        "approval_date": "Jun 1, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "May 9, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "May 9, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARMODAFINIL",
  "proprietary_name": "Armodafinil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA200043",
  "marketing_category": "ANDA",
  "nonproprietary_name": "armodafinil",
  "start_marketing_date": "20160601",
  "active_numerator_strength": "150"
}

Related drugs

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