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United States · US · US:0074-2310_6c4bad0a-5930-4bb7-8509-6a8c6f279082

Rinvoq

Orange BookUNIISPLATC L04AF03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeL04AF03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0074231020
    14 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2310-20)
  • ndc11
    0074231030
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2310-30)

Annotations

UNII (FDA Substance ID)
4RA0KN46E0
UPADACITINIB
RxCUI 2196092
Orange Book
N211675
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4RA0KN46E0",
    "rxcui": "2196092",
    "inchikey": "WYQFJHHDOKWSHR-MNOVXSKESA-N",
    "display_name": "UPADACITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2966aec7-2ef0-923c-d8ff-fe1a957bf095": {
      "match": "brand_token",
      "title": "RINVOQ (UPADACITINIB) TABLET, EXTENDED RELEASE RINVOQ (UPADACITINIB) SOLUTION [ABBVIE INC.]",
      "spl_version": "100",
      "published_date": "2026-04-30"
    }
  },
  "productid": "0074-2310_6c4bad0a-5930-4bb7-8509-6a8c6f279082",
  "productndc": "0074-2310",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211675",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Aug 16, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "45MG",
        "product_no": "003",
        "approval_date": "Mar 16, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "UPADACITINIB",
  "proprietary_name": "Rinvoq",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211675",
  "marketing_category": "NDA",
  "nonproprietary_name": "Upadacitinib",
  "start_marketing_date": "20190816",
  "active_numerator_strength": "30"
}

Related drugs

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