sirolimus

Orange BookUNIISPLATC S01XA23

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeS01XA23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051844490
100 POUCH in 1 BOX (70518-4449-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4449-1)

Annotations

UNII (FDA Substance ID)

W36ZG6FT64

SIROLIMUS

RxCUI 35302

Orange Book

A208691

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "W36ZG6FT64",
    "rxcui": "35302",
    "inchikey": "QFJCIRLUMZQUOT-HPLJOQBZSA-N",
    "display_name": "SIROLIMUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ad39eb60-1fa0-4722-8ba1-523194921c2a": {
      "match": "brand_token",
      "title": "SIROLIMUS TABLET, FILM COATED [NORTHSTAR RX LLC]",
      "spl_version": "4",
      "published_date": "2026-05-13"
    }
  },
  "productid": "70518-4449_3cbd5b5e-26f3-abc5-e063-6394a90a93eb",
  "productndc": "70518-4449",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208691",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Oct 16, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Oct 16, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Oct 16, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIROLIMUS",
  "proprietary_name": "sirolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208691",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sirolimus",
  "start_marketing_date": "20250819",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code S01XA23.

Access this data programmatically

Query sirolimus 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