Griseofulvin MICROSIZE

Orange BookUNIISPLATC D01AA08

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

Identification

ManufacturerChartwell RX, LLC.

CountryUS (United States)

ATC codeD01AA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6213549601
100 TABLET in 1 BOTTLE (62135-496-01)
ndc11
6213549630
30 TABLET in 1 BOTTLE (62135-496-30)

Annotations

UNII (FDA Substance ID)

32HRV3E3D5

GRISEOFULVIN

RxCUI 5021

Orange Book

A060569

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": "62135-496_2589e87e-f74c-cbf4-e063-6394a90a402f",
  "productndc": "62135-496",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "060569",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRISEOFULVIN",
  "proprietary_name": "Griseofulvin MICROSIZE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA060569",
  "marketing_category": "ANDA",
  "nonproprietary_name": "griseofulvin",
  "start_marketing_date": "19710909",
  "active_numerator_strength": "500"
}

Related drugs

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