Claravis

Orange BookUNIIATC D10BA01

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeD10BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0555105686
3 BLISTER PACK in 1 CARTON (0555-1056-86) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1056-60)

Annotations

UNII (FDA Substance ID)

EH28UP18IF

ISOTRETINOIN

RxCUI 6064

Orange Book

A076135

AB1AB1AB1

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": "0555-1056_a69dde5d-5585-4313-be43-02d11fec4c9f",
  "productndc": "0555-1056",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "076135",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB1",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Apr 11, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "May 11, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOTRETINOIN",
  "proprietary_name": "Claravis",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isotretinoin",
  "start_marketing_date": "20060518",
  "active_numerator_strength": "30"
}

Related drugs

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