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United States · US · US:67877-747_b6349068-caf8-4f40-959d-cb9f1b8dd2be

Sirolimus

Orange BookUNIISPLATC S01XA23

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeS01XA23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6787774701
    100 TABLET, FILM COATED in 1 BOTTLE (67877-747-01)
  • ndc11
    6787774705
    500 TABLET, FILM COATED in 1 BOTTLE (67877-747-05)
  • ndc11
    6787774730
    30 TABLET, FILM COATED in 1 BOTTLE (67877-747-30)
  • ndc11
    6787774738
    100 BLISTER PACK in 1 CARTON (67877-747-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-747-33)

Annotations

UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
A214753
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": "67877-747_b6349068-caf8-4f40-959d-cb9f1b8dd2be",
  "productndc": "67877-747",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214753",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Mar 12, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Mar 12, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Mar 12, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIROLIMUS",
  "proprietary_name": "Sirolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214753",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sirolimus",
  "start_marketing_date": "20210313",
  "active_numerator_strength": "1"
}

Related drugs

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