ULTRAMICROSIZE GRISEOFULVIN

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 · 1

ndc11
6213550130
30 TABLET in 1 BOTTLE (62135-501-30)

Annotations

UNII (FDA Substance ID)

32HRV3E3D5

GRISEOFULVIN

RxCUI 5021

Orange Book

A061996

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": "62135-501_2e9858c1-8c99-8a0d-e063-6294a90a59a5",
  "productndc": "62135-501",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "061996",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "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"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "165MG",
        "product_no": "003",
        "approval_date": "Apr 6, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "330MG",
        "product_no": "004",
        "approval_date": "Apr 6, 1982"
      }
    ],
    "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": "ANDA061996",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ULTRAMICROSIZE GRISEOFULVIN",
  "start_marketing_date": "19820406",
  "active_numerator_strength": "165"
}

Related drugs

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