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 · 10

ndc11
7133525010
100 TABLET in 1 BOTTLE, PLASTIC (71335-2501-0)
ndc11
7133525011
30 TABLET in 1 BOTTLE, PLASTIC (71335-2501-1)
ndc11
7133525012
18 TABLET in 1 BOTTLE, PLASTIC (71335-2501-2)
ndc11
7133525013
16 TABLET in 1 BOTTLE, PLASTIC (71335-2501-3)
ndc11
7133525014
8 TABLET in 1 BOTTLE, PLASTIC (71335-2501-4)
ndc11
7133525015
10 TABLET in 1 BOTTLE, PLASTIC (71335-2501-5)
ndc11
7133525016
60 TABLET in 1 BOTTLE, PLASTIC (71335-2501-6)
ndc11
7133525017
90 TABLET in 1 BOTTLE, PLASTIC (71335-2501-7)
ndc11
7133525018
45 TABLET in 1 BOTTLE, PLASTIC (71335-2501-8)
ndc11
7133525019
180 TABLET in 1 BOTTLE, PLASTIC (71335-2501-9)

Annotations

UNII (FDA Substance ID)

R3UK8X3U3D

MODAFINIL

RxCUI 30125

Orange Book

A207196

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": "71335-2501_08b24ff6-853b-4b93-bdfc-0deb84c837b4",
  "productndc": "71335-2501",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207196",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Aug 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MODAFINIL",
  "proprietary_name": "Modafinil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207196",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Modafinil",
  "start_marketing_date": "20240221",
  "active_numerator_strength": "200"
}

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