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
7051843760
100 POUCH in 1 BOX (70518-4376-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4376-1)

Annotations

UNII (FDA Substance ID)

W36ZG6FT64

SIROLIMUS

RxCUI 35302

Orange Book

A201676

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": "70518-4376_38c957b7-27e3-d35c-e063-6294a90aa511",
  "productndc": "70518-4376",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201676",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Feb 15, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Feb 15, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "003",
        "approval_date": "Jan 8, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIROLIMUS",
  "proprietary_name": "sirolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201676",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sirolimus",
  "start_marketing_date": "20250628",
  "active_numerator_strength": ".5"
}

Related drugs

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