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United States · US · US:71335-2258_1edff16c-5323-43d1-9896-dfc4a4ebf243

Modafinil

Orange BookUNIISPLATC N06BA07

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

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
    7133522580
    100 TABLET in 1 BOTTLE (71335-2258-0)
  • ndc11
    7133522581
    30 TABLET in 1 BOTTLE (71335-2258-1)
  • ndc11
    7133522582
    18 TABLET in 1 BOTTLE (71335-2258-2)
  • ndc11
    7133522583
    16 TABLET in 1 BOTTLE (71335-2258-3)
  • ndc11
    7133522584
    8 TABLET in 1 BOTTLE (71335-2258-4)
  • ndc11
    7133522585
    10 TABLET in 1 BOTTLE (71335-2258-5)
  • ndc11
    7133522586
    60 TABLET in 1 BOTTLE (71335-2258-6)
  • ndc11
    7133522587
    90 TABLET in 1 BOTTLE (71335-2258-7)
  • ndc11
    7133522588
    45 TABLET in 1 BOTTLE (71335-2258-8)
  • ndc11
    7133522589
    180 TABLET in 1 BOTTLE (71335-2258-9)

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": "71335-2258_1edff16c-5323-43d1-9896-dfc4a4ebf243",
  "productndc": "71335-2258",
  "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": "20210218",
  "active_numerator_strength": "200"
}

Related drugs

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