Isotretinoin

Orange BookUNIISPLATC D10BA01

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeD10BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071015778
3 BLISTER PACK in 1 CARTON (70710-1577-8) / 10 CAPSULE in 1 BLISTER PACK (70710-1577-2)

Annotations

UNII (FDA Substance ID)

EH28UP18IF

ISOTRETINOIN

RxCUI 6064

Orange Book

A216633

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": "70710-1577_a5b78223-8bce-490b-a83c-e342c25c082a",
  "productndc": "70710-1577",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "216633",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "35MG",
        "product_no": "005",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "40MG",
        "product_no": "006",
        "approval_date": "May 22, 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": "ANDA216633",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isotretinoin",
  "start_marketing_date": "20250609",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code D10BA01.

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