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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0169-77030169-7703-11DDiscontinued by firm2026-08-17
excluded packagepackage0169-77030169-7703-91DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050169-7703-91d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050169-7703-11d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260169-7703-91f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260169-7703-11f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310169-7703-912ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310169-7703-112ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280169-7703-91a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280169-7703-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210169-7703-91cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210169-7703-11cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100169-7703-91cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100169-7703-11cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310169-7703-91302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310169-7703-11302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200169-7703-91ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200169-7703-11ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100169-7703-910efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100169-7703-110efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080169-7703-91ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080169-7703-11ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030169-7703-91367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030169-7703-11367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090169-7703-91557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090169-7703-11557ba5c1ecfa…9c80585c8c6e…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NQX9KB6PCLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
847243Internal RxNorm lookup
847245Internal RxNorm lookup
847247Internal RxNorm lookup
847348Internal RxNorm lookup
849850Internal RxNorm lookup
849851Internal RxNorm lookup
1736262Internal RxNorm lookup
1736329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1058e17c-9261-459c-a3e6-fae38d196c14Available on FDA.report

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorditropinSOMATROPINNovo Nordisk1058e17c-9261-459c-a3e6-fae38d196c142025-07-07Warnings, Adverse reactionsExact identifier
application number: BLA021148
ndc (product): 0169-7703

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021148Norditropinsomatropin351(a)Disc2026-07-01

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