Insulin Degludec

Product NDC
73070-503
11-digit product format
730700503
Labeler code
73070
Product ID
73070-503_c1be283d-4b1d-4996-b2a7-4488dbff3037
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin degludec
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk Pharma, Inc.
Application
BLA203314
Marketing category
BLA
Marketing start
2022-07-01
Substance
INSULIN DEGLUDEC
Active strength
200 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 DEGLUDEC200 U/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii54Q18076QB
Rxcui1670011, 1670021, 2107520

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
73070-503-15Insulin Degludec3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION31
73070-503-15Insulin Degludec3 in 1 CARTONINJECTION, SOLUTION31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73070-503-15ML - Milliliter73070-5030fd9ab14-b7d8-4440-8d37-f266f1c2223112022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73070-503INSULIN DEGLUDEC INJECTION, SOLUTION [NOVO NORDISK PHARMA, INC.]1Current NDC, Legacy NDC, 2 package rows20220717_c1be283d-4b1d-4996-b2a7-4488dbff3037.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670011insulin degludec 100 UNT/ML in 3 ML Pen InjectorPSNc1be283d-4b1d-4996-b2a7-4488dbff30371
2107520insulin degludec 100 UNT/mL Injectable SolutionPSNc1be283d-4b1d-4996-b2a7-4488dbff30371
1670021insulin degludec 200 UNT/ML in 3 ML Pen InjectorPSN62128c8b-f613-44d9-af04-18d52c4348cd1
1670021insulin degludec 200 UNT/ML in 3 ML Pen InjectorPSNc1be283d-4b1d-4996-b2a7-4488dbff30371
16700113 ML insulin degludec 100 UNT/ML Pen InjectorSCDc1be283d-4b1d-4996-b2a7-4488dbff30371
16700213 ML insulin degludec 200 UNT/ML Pen InjectorSCD62128c8b-f613-44d9-af04-18d52c4348cd1
16700213 ML insulin degludec 200 UNT/ML Pen InjectorSCDc1be283d-4b1d-4996-b2a7-4488dbff30371
2107520insulin degludec 100 UNT/ML Injectable SolutionSCDc1be283d-4b1d-4996-b2a7-4488dbff30371
1670011insulin degludec 100 UNT/ML per 3 ML Pen InjectorSYc1be283d-4b1d-4996-b2a7-4488dbff30371
1670021insulin degludec 200 UNT/ML per 3 ML Pen InjectorSY62128c8b-f613-44d9-af04-18d52c4348cd1
1670021insulin degludec 200 UNT/ML per 3 ML Pen InjectorSYc1be283d-4b1d-4996-b2a7-4488dbff30371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73070-503-15730700503153 SYRINGE, PLASTIC in 1 CARTON (73070-503-15) / 3 mL in 1 SYRINGE, PLASTIC2022-07-010000-00-00NoNoCurrent