temsirolimus

Generic: temsirolimus

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temsirolimus
Generic Name temsirolimus
Labeler fresenius kabi usa, llc
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-200
Product ID 65219-200_2b33d5f1-198e-41ef-ac78-ccfd27fc137a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207383
Listing Expiration 2026-12-31
Marketing Start 2020-11-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219200
Hyphenated Format 65219-200

Supplemental Identifiers

RxCUI
722289

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name temsirolimus (source: ndc)
Generic Name temsirolimus (source: ndc)
Application Number ANDA207383 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/ml
  • 0.2 ml
  • 1.8 ml
  • 2.2 ml
source: label
Packaging
  • 1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05)
source: ndc

Packages (1)

65219-200-05 1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Temsirolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2b33d5f1-198e-41ef-ac78-ccfd27fc137a", "openfda": {"rxcui": ["722289"], "spl_set_id": ["1c207bed-10e3-46f0-ad2c-69d5e5c97736"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (65219-200-05)  *  1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05)  *  1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05)", "package_ndc": "65219-200-05", "marketing_start_date": "20201120"}], "brand_name": "Temsirolimus", "product_id": "65219-200_2b33d5f1-198e-41ef-ac78-ccfd27fc137a", "dosage_form": "KIT", "product_ndc": "65219-200", "generic_name": "Temsirolimus", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temsirolimus", "application_number": "ANDA207383", "marketing_category": "ANDA", "marketing_start_date": "20201120", "listing_expiration_date": "20261231"}