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United States · US · US:0781-5515_79afc7a7-d77e-48eb-b1c6-6ea974801f38

Griseofulvin

Orange BookUNIISPLATC D01AA08

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeD01AA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0781551501
    100 TABLET in 1 BOTTLE (0781-5515-01)
  • ndc11
    0781551505
    500 TABLET in 1 BOTTLE (0781-5515-05)

Annotations

UNII (FDA Substance ID)
32HRV3E3D5
GRISEOFULVIN
RxCUI 5021
Orange Book
A091592
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "32HRV3E3D5",
    "rxcui": "5021",
    "inchikey": "DDUHZTYCFQRHIY-RBHXEPJQSA-N",
    "display_name": "GRISEOFULVIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "98829d90-b289-4bec-a625-7af412a5cb2d": {
      "match": "brand_token",
      "title": "GRISEOFULVIN TABLET [SANDOZ INC]",
      "spl_version": "4",
      "published_date": "2025-11-21"
    }
  },
  "productid": "0781-5515_79afc7a7-d77e-48eb-b1c6-6ea974801f38",
  "productndc": "0781-5515",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091592",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Aug 7, 2013"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Aug 7, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRISEOFULVIN",
  "proprietary_name": "Griseofulvin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091592",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Griseofulvin",
  "start_marketing_date": "20130807",
  "active_numerator_strength": "500"
}

Related drugs

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