ZENATANE

Orange BookUNIISPLATC D10BA01

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

Identification

ManufacturerBluePoint Laboratories

CountryUS (United States)

ATC codeD10BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6800165217
3 BLISTER PACK in 1 CARTON (68001-652-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-652-16)

Annotations

UNII (FDA Substance ID)

EH28UP18IF

ISOTRETINOIN

RxCUI 6064

Orange Book

A202099

AB1AB1AB1AB1

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": {
    "486d4a4b-0de5-431a-bef7-dae6b0e4fa20": {
      "match": "brand_token",
      "title": "ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [BLUEPOINT LABORATORIES]",
      "spl_version": "4",
      "published_date": "2026-04-03"
    }
  },
  "productid": "68001-652_4e69c221-c1ba-9b55-e063-6394a90afbd4",
  "productndc": "68001-652",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "202099",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 25, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Mar 25, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Mar 25, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Feb 23, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOTRETINOIN",
  "proprietary_name": "ZENATANE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202099",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ISOTRETINOIN",
  "start_marketing_date": "20251230",
  "active_numerator_strength": "10"
}

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