temsirolimus

Generic: temsirolimus injection

Labeler: almaject, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temsirolimus
Generic Name temsirolimus injection
Labeler almaject, inc.
Dosage Form KIT
Manufacturer
Almaject, Inc.

Identifiers & Regulatory

Product NDC 72611-785
Product ID 72611-785_b2939aa0-0685-5031-41aa-3ecea4025e89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207383
Listing Expiration 2026-12-31
Marketing Start 2020-05-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72611785
Hyphenated Format 72611-785

Supplemental Identifiers

RxCUI
722289
UPC
0372611785028

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 injection (source: ndc)
Application Number ANDA207383 (source: ndc)

Resolved Composition

Strengths
  • 25 mg/ml
  • 0.2 ml
  • 1.8 ml
  • 2.2 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (72611-785-02) * 1.8 mL in 1 VIAL, SINGLE-DOSE (72611-782-01) * 1 mL in 1 VIAL, SINGLE-DOSE (72611-780-01)
source: ndc

Packages (1)

72611-785-02 1 KIT in 1 CARTON (72611-785-02) * 1.8 mL in 1 VIAL, SINGLE-DOSE (72611-782-01) * 1 mL in 1 VIAL, SINGLE-DOSE (72611-780-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Temsirolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "b2939aa0-0685-5031-41aa-3ecea4025e89", "openfda": {"upc": ["0372611785028"], "rxcui": ["722289"], "spl_set_id": ["a1f129ff-c0a4-ede7-ae9c-7a3cfa01fe12"], "manufacturer_name": ["Almaject, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (72611-785-02)  *  1.8 mL in 1 VIAL, SINGLE-DOSE (72611-782-01)  *  1 mL in 1 VIAL, SINGLE-DOSE (72611-780-01)", "package_ndc": "72611-785-02", "marketing_start_date": "20200508"}], "brand_name": "Temsirolimus", "product_id": "72611-785_b2939aa0-0685-5031-41aa-3ecea4025e89", "dosage_form": "KIT", "product_ndc": "72611-785", "generic_name": "Temsirolimus Injection", "labeler_name": "Almaject, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temsirolimus", "application_number": "ANDA207383", "marketing_category": "ANDA", "marketing_start_date": "20200508", "listing_expiration_date": "20261231"}