Amnesteem

Orange BookUNIISPLATC D10BA01

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeD10BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378661393
3 BLISTER PACK in 1 CARTON (0378-6613-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6613-85)

Annotations

UNII (FDA Substance ID)

EH28UP18IF

ISOTRETINOIN

RxCUI 6064

Orange Book

A075945

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": {
    "b2cb63c9-f825-4991-9a2c-6260f1bbcc2c": {
      "match": "brand_token",
      "title": "AMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "23",
      "published_date": "2025-07-11"
    }
  },
  "productid": "0378-6613_8105505f-9df6-4bc4-b201-7281a2d3af00",
  "productndc": "0378-6613",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075945",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 8, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Nov 8, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Nov 8, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Mar 17, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOTRETINOIN",
  "proprietary_name": "Amnesteem",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075945",
  "marketing_category": "ANDA",
  "nonproprietary_name": "isotretinoin",
  "start_marketing_date": "20250410",
  "active_numerator_strength": "30"
}

Related drugs

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