TRESIBA

Product NDC
50090-7077
11-digit product format
500907077
Labeler code
50090
Product ID
50090-7077_cc399f8e-7e57-48bd-993c-2104a4b1acf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin degludec
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA203314
Marketing category
BLA
Marketing start
2015-09-25
Substance
INSULIN DEGLUDEC
Active strength
100 U/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
54Q18076QBINSULIN DEGLUDEC844439-96-9INSULIN DEGLUDEC

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7077-0500907077005 SYRINGE, PLASTIC in 1 CARTON (50090-7077-0) / 3 mL in 1 SYRINGE, PLASTIC2024-01-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TRESIBAA-S Medication Solutions2024-02-01HUMAN PRESCRIPTION DRUG LABEL1