tresiba

Generic: insulin degludec

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tresiba
Generic Name insulin degludec
Labeler a-s medication solutions
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin degludec 200 U/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3491
Product ID 50090-3491_ee96b54f-5204-4b1b-8e9c-593f56045b66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA203314
Listing Expiration 2026-12-31
Marketing Start 2015-09-25

Pharmacologic Class

Established (EPC)
insulin analog [epc]
Chemical Structure
insulin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500903491
Hyphenated Format 50090-3491

Supplemental Identifiers

RxCUI
1670021 1670023
UNII
54Q18076QB
NUI
M0011417 N0000175453

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 tresiba (source: ndc)
Generic Name insulin degludec (source: ndc)
Application Number BLA203314 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 U/mL
source: ndc
Packaging
  • 3 SYRINGE, PLASTIC in 1 CARTON (50090-3491-0) / 3 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

50090-3491-0 3 SYRINGE, PLASTIC in 1 CARTON (50090-3491-0) / 3 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

insulin degludec (200 U/mL)

Linked Drug Pages (1)

Tresiba ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ee96b54f-5204-4b1b-8e9c-593f56045b66", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["54Q18076QB"], "rxcui": ["1670021", "1670023"], "spl_set_id": ["84197351-cb71-4282-8217-13103404a2b4"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "3 SYRINGE, PLASTIC in 1 CARTON (50090-3491-0)  / 3 mL in 1 SYRINGE, PLASTIC", "package_ndc": "50090-3491-0", "marketing_start_date": "20180620"}], "brand_name": "Tresiba", "product_id": "50090-3491_ee96b54f-5204-4b1b-8e9c-593f56045b66", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "50090-3491", "generic_name": "insulin degludec", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tresiba", "active_ingredients": [{"name": "INSULIN DEGLUDEC", "strength": "200 U/mL"}], "application_number": "BLA203314", "marketing_category": "BLA", "marketing_start_date": "20150925", "listing_expiration_date": "20261231"}