Isotretinoin

Orange BookUNIISPLATC D10BA01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeD10BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5766402197
3 BLISTER PACK in 1 BOX (57664-021-97) / 10 CAPSULE in 1 BLISTER PACK (57664-021-98)

Annotations

UNII (FDA Substance ID)

EH28UP18IF

ISOTRETINOIN

RxCUI 6064

Orange Book

N021951

AB2AB2AB2AB2AB2AB2

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": "57664-021_0e924cf6-5375-28c4-e063-6294a90a4ac4",
  "productndc": "57664-021",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021951",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 25, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "May 25, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "May 25, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "May 25, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "25MG",
        "product_no": "005",
        "approval_date": "Aug 15, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "35MG",
        "product_no": "006",
        "approval_date": "Aug 15, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOTRETINOIN",
  "proprietary_name": "Isotretinoin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021951",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Isotretinoin",
  "start_marketing_date": "20201229",
  "active_numerator_strength": "20"
}

Related drugs

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