Absorica LD

Orange BookUNIIATC 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
1063100231
3 BLISTER PACK in 1 BOX (10631-002-31) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

EH28UP18IF

ISOTRETINOIN

RxCUI 6064

Orange Book

N211913

Raw payload (JSON)

{
  "unii": {
    "unii": "EH28UP18IF",
    "rxcui": "6064",
    "inchikey": "SHGAZHPCJJPHSC-XFYACQKRSA-N",
    "display_name": "ISOTRETINOIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "10631-002_fba81535-0761-42a7-b422-338f8bd2cfc6",
  "productndc": "10631-002",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211913",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "8MG",
        "product_no": "001",
        "approval_date": "Nov 5, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "16MG",
        "product_no": "002",
        "approval_date": "Nov 5, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 5, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "24MG",
        "product_no": "004",
        "approval_date": "Nov 5, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "28MG",
        "product_no": "005",
        "approval_date": "Nov 5, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "32MG",
        "product_no": "006",
        "approval_date": "Nov 5, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOTRETINOIN",
  "proprietary_name": "Absorica LD",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211913",
  "marketing_category": "NDA",
  "nonproprietary_name": "isotretinoin",
  "start_marketing_date": "20191120",
  "active_numerator_strength": "8"
}

Related drugs

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