sirolimus

Orange BookUNIISPLATC S01XA23

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeS01XA23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846268401
100 TABLET, FILM COATED in 1 BOTTLE (68462-684-01)

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": "68462-684_72132b30-e98c-4f0c-9fb7-ecb63ba18224",
  "productndc": "68462-684",
  "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": "20201016",
  "active_numerator_strength": "2"
}

Related drugs

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