Modafinil

Orange BookUNIISPLATC N06BA07

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeN06BA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4670838510
100 TABLET in 1 CARTON (46708-385-10)
ndc11
4670838530
30 TABLET in 1 BOTTLE (46708-385-30)
ndc11
4670838560
60 TABLET in 1 BOTTLE (46708-385-60)
ndc11
4670838590
90 TABLET in 1 BOTTLE (46708-385-90)
ndc11
4670838591
1000 TABLET in 1 BOTTLE (46708-385-91)

Annotations

UNII (FDA Substance ID)

R3UK8X3U3D

MODAFINIL

RxCUI 30125

Orange Book

A202700

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": "46708-385_975cac47-5a4b-4a5d-a8c5-2aea808f30ca",
  "productndc": "46708-385",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202700",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Oct 18, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Oct 18, 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": "ANDA202700",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Modafinil",
  "start_marketing_date": "20170630",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N06BA07.

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