Isotretinoin

Orange BookUNIISPLATC D10BA01

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeD10BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7077115584
10 BLISTER PACK in 1 CARTON (70771-1558-4) / 10 CAPSULE in 1 BLISTER PACK
ndc11
7077115588
3 BLISTER PACK in 1 CARTON (70771-1558-8) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

EH28UP18IF

ISOTRETINOIN

RxCUI 6064

Orange Book

A211568

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": {
    "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": "70771-1558_b071eb5c-28f7-4b86-b4e9-7c98da2f19df",
  "productndc": "70771-1558",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211568",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Aug 29, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Aug 29, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Aug 29, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOTRETINOIN",
  "proprietary_name": "Isotretinoin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211568",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isotretinoin",
  "start_marketing_date": "20230912",
  "active_numerator_strength": "20"
}

Related drugs

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