Insulin Degludec

Product NDC
50090-7176
11-digit product format
500907176
Labeler code
50090
Product ID
50090-7176_36cbe8bf-7f0b-4361-93dc-280bdaa7f9cd
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
2022-07-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Insulin Degludec
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN DEGLUDEC100 U/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii54Q18076QB
Rxcui1670011

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0dd952e2-ff48-4739-9b8d-72ae0b326834Product name220200323
34796cf9-f067-40c8-ac2d-d04e5b83ae05Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7176-0Insulin Degludec5 in 1 CARTONINJECTION, SOLUTION51
50090-7176-0Insulin Degludec3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7176-0ML - Milliliter50090-7176de59124e-a708-48c7-8952-fcd0f190ff9e12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7176INSULIN DEGLUDEC INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240604_7a4bd8e5-7af4-4573-97c2-9945faf6a7dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670011insulin degludec 100 UNT/ML in 3 ML Pen InjectorPSN7a4bd8e5-7af4-4573-97c2-9945faf6a7dd1
16700113 ML insulin degludec 100 UNT/ML Pen InjectorSCD7a4bd8e5-7af4-4573-97c2-9945faf6a7dd1
1670011insulin degludec 100 UNT/ML per 3 ML Pen InjectorSY7a4bd8e5-7af4-4573-97c2-9945faf6a7dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7176-0500907176005 SYRINGE, PLASTIC in 1 CARTON (50090-7176-0) / 3 mL in 1 SYRINGE, PLASTIC2024-05-29NoNoCurrent