Ultramicrosize Griseofulvin

Orange BookUNIISPLATC D01AA08

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

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC codeD01AA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0781582701
100 TABLET, COATED in 1 BOTTLE (0781-5827-01)
ndc11
0781582705
500 TABLET, COATED in 1 BOTTLE (0781-5827-05)

Annotations

UNII (FDA Substance ID)

32HRV3E3D5

GRISEOFULVIN

RxCUI 5021

Orange Book

A202805

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": {
    "f21314eb-3581-4e06-9fe7-8239cc80ba11": {
      "match": "brand_token",
      "title": "ULTRAMICROSIZE GRISEOFULVIN (ULTRAMICROSIZE GRISEOFULVIN TABLETS) TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "7",
      "published_date": "2025-12-22"
    }
  },
  "productid": "0781-5827_6d66c19d-0069-4a47-a45c-567aa0398135",
  "productndc": "0781-5827",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "202805",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Dec 26, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Dec 26, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRISEOFULVIN",
  "proprietary_name": "Ultramicrosize Griseofulvin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202805",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ultramicrosize Griseofulvin",
  "start_marketing_date": "20200401",
  "active_numerator_strength": "125"
}

Related drugs

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