FDA.reportPublic FDA data

Norditropin

Product NDC
0169-7703
11-digit product format
001697703
Labeler code
0169
Product ID
0169-7703_b67c2419-4feb-4ce1-b97e-88760a8e1aee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
somatropin
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
BLA021148
Marketing category
BLA
Marketing start
2009-03-30
Substance
SOMATROPIN
Active strength
30 mg/3mL
Pharmacologic classes
Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOMATROPIN30 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNQX9KB6PCL
Rxcui847243, 847245, 847247, 847348, 849850, 849851, 1736262, 1736329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-7703-11Norditropin3 mL in 1 SYRINGEINJECTION, SOLUTION330
0169-7703-11Norditropin1 in 1 CARTONINJECTION, SOLUTION130
0169-7703-21Norditropin1 in 1 CARTONINJECTION, SOLUTION130
0169-7703-21Norditropin3 mL in 1 SYRINGEINJECTION, SOLUTION330
0169-7703-91Norditropin3 mL in 1 SYRINGEINJECTION, SOLUTION330
0169-7703-91Norditropin1 in 1 CARTONINJECTION, SOLUTION130
0169-7703-92Norditropin1 in 1 CARTONINJECTION, SOLUTION130
0169-7703-92Norditropin3 mL in 1 SYRINGEINJECTION, SOLUTION330

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-7703-11ML - Milliliter0169-77032b5d81ef-6313-4745-85b7-a6d5115f6a3d12012-07-24
0169-7703-21ML - Milliliter0169-77036a16a5f2-c0af-4ed0-9030-dc955234c56d12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOMATROPINACTIVE INGREDIENTNQX9KB6PCLNORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15
SOMATROPINACTIVE MOIETYNQX9KB6PCLNORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15
HISTIDINEINACTIVE INGREDIENT4QD397987ENORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15
MANNITOLINACTIVE INGREDIENT3OWL53L36ANORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15
PHENOLINACTIVE INGREDIENT339NCG44TVNORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGNORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15
WATERINACTIVE INGREDIENT059QF0KO0RNORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-7703NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]28Current NDC, Legacy NDC, 8 package rows20250216_1058e17c-9261-459c-a3e6-fae38d196c14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847348Norditropin 10 MG in 1.5 ML Pen InjectorPSN1058e17c-9261-459c-a3e6-fae38d196c1430
847245Norditropin 15 MG in 1.5 ML Pen InjectorPSN1058e17c-9261-459c-a3e6-fae38d196c1430
849851Norditropin 30 MG in 3 ML Pen InjectorPSN1058e17c-9261-459c-a3e6-fae38d196c1430
847247Norditropin 5 MG in 1.5 ML Pen InjectorPSN1058e17c-9261-459c-a3e6-fae38d196c1430
1736329somatropin 10 MG in 1.5 ML Pen InjectorPSN1058e17c-9261-459c-a3e6-fae38d196c1430
847243somatropin 15 MG in 1.5 ML Pen InjectorPSN1058e17c-9261-459c-a3e6-fae38d196c1430
849850somatropin 30 MG in 3 ML Pen InjectorPSN1058e17c-9261-459c-a3e6-fae38d196c1430
1736262somatropin 5 MG in 1.5 ML Pen InjectorPSN1058e17c-9261-459c-a3e6-fae38d196c1430
8472451.5 ML somatropin 10 MG/ML Pen Injector [Norditropin]SBD1058e17c-9261-459c-a3e6-fae38d196c1430
8472471.5 ML somatropin 3.33 MG/ML Pen Injector [Norditropin]SBD1058e17c-9261-459c-a3e6-fae38d196c1430
8473481.5 ML somatropin 6.67 MG/ML Pen Injector [Norditropin]SBD1058e17c-9261-459c-a3e6-fae38d196c1430
8498513 ML somatropin 10 MG/ML Pen Injector [Norditropin]SBD1058e17c-9261-459c-a3e6-fae38d196c1430
8472431.5 ML somatropin 10 MG/ML Pen InjectorSCD1058e17c-9261-459c-a3e6-fae38d196c1430
17362621.5 ML somatropin 3.33 MG/ML Pen InjectorSCD1058e17c-9261-459c-a3e6-fae38d196c1430
17363291.5 ML somatropin 6.67 MG/ML Pen InjectorSCD1058e17c-9261-459c-a3e6-fae38d196c1430
8498503 ML somatropin 10 MG/ML Pen InjectorSCD1058e17c-9261-459c-a3e6-fae38d196c1430
847348Norditropin 10 MG per 1.5 ML Pen InjectorSY1058e17c-9261-459c-a3e6-fae38d196c1430
847245Norditropin 15 MG per 1.5 ML Pen InjectorSY1058e17c-9261-459c-a3e6-fae38d196c1430
849851Norditropin 30 MG per 3 ML Pen InjectorSY1058e17c-9261-459c-a3e6-fae38d196c1430
847247Norditropin 5 MG per 1.5 ML Pen InjectorSY1058e17c-9261-459c-a3e6-fae38d196c1430
1736329somatropin 10 MG per 1.5 ML Pen InjectorSY1058e17c-9261-459c-a3e6-fae38d196c1430
847243somatropin 15 MG per 1.5 ML Pen InjectorSY1058e17c-9261-459c-a3e6-fae38d196c1430
849850somatropin 30 MG per 3 ML Pen InjectorSY1058e17c-9261-459c-a3e6-fae38d196c1430
1736262somatropin 5 MG per 1.5 ML Pen InjectorSY1058e17c-9261-459c-a3e6-fae38d196c1430

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-7703-11001697703113 mL in 1 SYRINGE3 mlHistorical
0169-7703-21001697703211 SYRINGE in 1 CARTON (0169-7703-21) / 3 mL in 1 SYRINGE1 syringe2015-01-230000-00-00NoNoCurrent
0169-7703-91001697703913 mL in 1 SYRINGE3 mlHistorical
0169-7703-92001697703921 SYRINGE in 1 CARTON (0169-7703-92) / 3 mL in 1 SYRINGE1 syringe2015-01-230000-00-00NoNoCurrent