temsirolimus

Generic: temsirolimus

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name temsirolimus
Generic Name temsirolimus
Labeler accord healthcare inc.
Dosage Form KIT
Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-223
Product ID 16729-223_116814b6-e438-8a45-e063-6394a90a9fad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203153
Listing Expiration 2026-12-31
Marketing Start 2018-08-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729223
Hyphenated Format 16729-223

Supplemental Identifiers

RxCUI
722289
UPC
0316729222303

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 ANDA203153 (source: ndc)

Resolved Composition

Strengths
  • 25 mg/ml
  • 0.2 ml
  • 1.8 ml
source: label
Packaging
  • 1 KIT in 1 KIT (16729-223-61) * 1 mL in 1 VIAL, SINGLE-DOSE (16729-221-30) * 1.8 mL in 1 VIAL, SINGLE-DOSE (16729-222-30)
source: ndc

Packages (1)

16729-223-61 1 KIT in 1 KIT (16729-223-61) * 1 mL in 1 VIAL, SINGLE-DOSE (16729-221-30) * 1.8 mL in 1 VIAL, SINGLE-DOSE (16729-222-30)

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": "116814b6-e438-8a45-e063-6394a90a9fad", "openfda": {"upc": ["0316729222303"], "rxcui": ["722289"], "spl_set_id": ["ae8d2354-7ddb-41b8-9d55-77c84782b18f"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (16729-223-61)  *  1 mL in 1 VIAL, SINGLE-DOSE (16729-221-30)  *  1.8 mL in 1 VIAL, SINGLE-DOSE (16729-222-30)", "package_ndc": "16729-223-61", "marketing_start_date": "20180813"}], "brand_name": "Temsirolimus", "product_id": "16729-223_116814b6-e438-8a45-e063-6394a90a9fad", "dosage_form": "KIT", "product_ndc": "16729-223", "generic_name": "temsirolimus", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Temsirolimus", "application_number": "ANDA203153", "marketing_category": "ANDA", "marketing_start_date": "20180813", "listing_expiration_date": "20261231"}