Ultramicrosize Griseofulvin

Orange BookUNIISPLATC D01AA08

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

Identification

ManufacturerHeritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc

CountryUS (United States)

ATC codeD01AA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2315586301
100 TABLET in 1 BOTTLE, PLASTIC (23155-863-01)

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": "23155-863_db35c070-b434-48f2-8ce8-e902d498459a",
  "productndc": "23155-863",
  "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": "Griseofulvin",
  "start_marketing_date": "20230630",
  "active_numerator_strength": "125"
}

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