Modafinil

Orange BookUNIISPLATC N06BA07

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN06BA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7133511221
30 TABLET in 1 BOTTLE (71335-1122-1)
ndc11
7133511222
60 TABLET in 1 BOTTLE (71335-1122-2)
ndc11
7133511223
28 TABLET in 1 BOTTLE (71335-1122-3)
ndc11
7133511224
90 TABLET in 1 BOTTLE (71335-1122-4)
ndc11
7133511225
45 TABLET in 1 BOTTLE (71335-1122-5)
ndc11
7133511226
180 TABLET in 1 BOTTLE (71335-1122-6)
ndc11
7133511227
100 TABLET in 1 BOTTLE (71335-1122-7)

Annotations

UNII (FDA Substance ID)

R3UK8X3U3D

MODAFINIL

RxCUI 30125

Orange Book

A202566

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": "71335-1122_0c6f0c70-8e9e-4d04-bd7d-88bc33255611",
  "productndc": "71335-1122",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202566",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Sep 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Sep 27, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MODAFINIL",
  "proprietary_name": "Modafinil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202566",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Modafinil",
  "start_marketing_date": "20120927",
  "active_numerator_strength": "100"
}

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