temsirolimus

Generic: temsirolimus injection

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temsirolimus
Generic Name temsirolimus injection
Labeler gland pharma limited
Dosage Form KIT
Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-202
Product ID 68083-202_6dd61a73-2d62-4f94-9617-643d8b896fde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207383
Listing Expiration 2026-12-31
Marketing Start 2019-08-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083202
Hyphenated Format 68083-202

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 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 (68083-202-01) * 1 mL in 1 VIAL, SINGLE-USE (68083-200-01) * 1.8 mL in 1 VIAL, SINGLE-USE (68083-201-01)
source: ndc

Packages (1)

68083-202-01 1 KIT in 1 CARTON (68083-202-01) * 1 mL in 1 VIAL, SINGLE-USE (68083-200-01) * 1.8 mL in 1 VIAL, SINGLE-USE (68083-201-01)

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": "6dd61a73-2d62-4f94-9617-643d8b896fde", "openfda": {"rxcui": ["722289"], "spl_set_id": ["d7ee3165-175d-4439-8740-fbfed18aaf0e"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (68083-202-01)  *  1 mL in 1 VIAL, SINGLE-USE (68083-200-01)  *  1.8 mL in 1 VIAL, SINGLE-USE (68083-201-01)", "package_ndc": "68083-202-01", "marketing_start_date": "20190826"}], "brand_name": "Temsirolimus", "product_id": "68083-202_6dd61a73-2d62-4f94-9617-643d8b896fde", "dosage_form": "KIT", "product_ndc": "68083-202", "generic_name": "Temsirolimus Injection", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temsirolimus", "application_number": "ANDA207383", "marketing_category": "ANDA", "marketing_start_date": "20190826", "listing_expiration_date": "20261231"}