Isotretinoin

Orange BookUNIISPLATC D10BA01

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeD10BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923812593
3 BLISTER PACK in 1 BOX (69238-1259-3) / 10 CAPSULE in 1 BLISTER PACK (69238-1259-4)

Annotations

UNII (FDA Substance ID)

EH28UP18IF

ISOTRETINOIN

RxCUI 6064

Orange Book

A216097

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "EH28UP18IF",
    "rxcui": "6064",
    "inchikey": "SHGAZHPCJJPHSC-XFYACQKRSA-N",
    "display_name": "ISOTRETINOIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "08529687-26b2-41e5-b6fb-35b4c0d891fe": {
      "match": "brand_token",
      "title": "ISOTRETINOIN CAPSULE, LIQUID FILLED [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "4",
      "published_date": "2026-02-16"
    }
  },
  "productid": "69238-1259_831e90e7-4cd9-44e1-8f94-b136bcba2b5b",
  "productndc": "69238-1259",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "216097",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Oct 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Oct 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Oct 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "35MG",
        "product_no": "005",
        "approval_date": "Oct 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "40MG",
        "product_no": "006",
        "approval_date": "Oct 7, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOTRETINOIN",
  "proprietary_name": "Isotretinoin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216097",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isotretinoin",
  "start_marketing_date": "20251010",
  "active_numerator_strength": "40"
}

Related drugs

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