Otezla

Orange BookUNIISPLATC L04AA32

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

Identification

ManufacturerAmgen, Inc

CountryUS (United States)

ATC codeL04AA32

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5551351930
30 TABLET, FILM COATED in 1 BOTTLE (55513-519-30)

Annotations

UNII (FDA Substance ID)

UP7QBP99PN

APREMILAST

RxCUI 1492727

Orange Book

N205437

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "UP7QBP99PN",
    "rxcui": "1492727",
    "inchikey": "IMOZEMNVLZVGJZ-QGZVFWFLSA-N",
    "display_name": "APREMILAST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f6b1f516-4972-4d82-bced-113e47b41cc5": {
      "match": "brand_token",
      "title": "OTEZLA (APREMILAST) TABLET, FILM COATED OTEZLA (APREMILAST) KIT [AMGEN, INC]",
      "spl_version": "34",
      "published_date": "2026-01-23"
    }
  },
  "productid": "55513-519_d869faaf-a5ad-4b12-b427-06587d17787e",
  "productndc": "55513-519",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205437",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 21, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Mar 21, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Mar 21, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "APREMILAST",
  "proprietary_name": "Otezla",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205437",
  "marketing_category": "NDA",
  "nonproprietary_name": "apremilast",
  "start_marketing_date": "20250831",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code L04AA32.

Access this data programmatically

Query Otezla and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs