FDA.reportPublic FDA data

Insulin Degludec

Product NDC
73070-403
Requested package NDC
73070-403-15
11-digit product format
730700403
Labeler code
73070
Product ID
73070-403_6bb8d7a1-4fd3-4c63-8a88-910bbcb3f1ad
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
Marketing end
2027-12-31
Substance
INSULIN DEGLUDEC
Active strength
100 U/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Insulin Degludec

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN DEGLUDEC100 U/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
54Q18076QBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1670011Internal RxNorm lookup
1670021Internal RxNorm lookup
2107520Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1be283d-4b1d-4996-b2a7-4488dbff3037Available on FDA.report

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
73070-403-15Insulin Degludec3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION31
73070-403-15Insulin Degludec5 in 1 CARTONINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73070-403-15ML - Milliliter73070-40302acad58-0f5f-4a5b-bc5a-1a484b81b9d612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73070-403INSULIN DEGLUDEC INJECTION, SOLUTION [NOVO NORDISK PHARMA, INC.]1Current NDC, Legacy NDC, 2 package rows20220717_c1be283d-4b1d-4996-b2a7-4488dbff3037.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin DegludecINSULIN DEGLUDECA-S Medication Solutions7a4bd8e5-7af4-4573-97c2-9945faf6a7dd2024-06-03Warnings, Adverse reactionsExact identifier
application number: BLA203314
Insulin DegludecINSULIN DEGLUDECA-S Medication Solutions62128c8b-f613-44d9-af04-18d52c4348cd2024-05-31Warnings, Adverse reactionsExact identifier
application number: BLA203314
TRESIBAINSULIN DEGLUDECA-S Medication Solutionse8ccd2f4-6ba9-4839-87f8-4742dc9b1c172024-02-22Warnings, Adverse reactionsExact identifier
application number: BLA203314
TresibaINSULIN DEGLUDECA-S Medication Solutions84197351-cb71-4282-8217-13103404a2b42023-12-12Warnings, Adverse reactionsExact identifier
application number: BLA203314
Insulin DegludecINSULIN DEGLUDECNovo Nordisk Pharma, Inc.c1be283d-4b1d-4996-b2a7-4488dbff30372022-07-01Warnings, Adverse reactionsExact identifier
application number: BLA203314
ndc (package): 73070-403-15
ndc (product): 73070-403
ndc11 (package): 73070040315
TresibaINSULIN DEGLUDECNovo Nordisk456c5e87-3dfd-46fa-8ac0-c6128d4c97c62022-07-01Warnings, Adverse reactionsExact identifier
application number: BLA203314

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
203314Tresibainsulin degludec351(a)Rx2026-09-01

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
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 InjectorPSNc1be283d-4b1d-4996-b2a7-4488dbff30371
16700113 ML insulin degludec 100 UNT/ML Pen InjectorSCD7a4bd8e5-7af4-4573-97c2-9945faf6a7dd1
16700113 ML insulin degludec 100 UNT/ML Pen InjectorSCDc1be283d-4b1d-4996-b2a7-4488dbff30371
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 InjectorSY7a4bd8e5-7af4-4573-97c2-9945faf6a7dd1
1670011insulin degludec 100 UNT/ML per 3 ML Pen InjectorSYc1be283d-4b1d-4996-b2a7-4488dbff30371
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
73070-403-15730700403155 SYRINGE, PLASTIC in 1 CARTON (73070-403-15) / 3 mL in 1 SYRINGE, PLASTIC2022-07-012027-12-31NoNoCurrent