Norditropin

Product NDC: 0169-7704
11-digit product format: 001697704
Labeler code: 0169
Product ID: 0169-7704_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: 2005-01-03
Substance: SOMATROPIN
Active strength: 5 mg/1.5mL
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
Ingredient	Strength
SOMATROPIN	5 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NQX9KB6PCL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1058e17c-9261-459c-a3e6-fae38d196c14	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
79c101e4-e5e3-43d7-be20-f7477d1e7556	Product name	1	20241230
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
34b7b043-6d89-4d95-9bed-7f5f2b49e6ef	Product name	2	20200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04	Product name	2	20200325
739a54c2-5f56-495a-aa67-4295fbc1cc86	Product name	2	20200325
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0169-7704-21	Norditropin	1 in 1 CARTON	INJECTION, SOLUTION	1	30
0169-7704-21	Norditropin	1.5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	1.5	30
0169-7704-92	Norditropin	1.5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	1.5	30
0169-7704-92	Norditropin	1 in 1 CARTON	INJECTION, SOLUTION	1	30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-7704-21	ML - Milliliter	0169-7704	946d8331-55cb-4c01-b195-7290c81580be	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SOMATROPIN	ACTIVE INGREDIENT	NQX9KB6PCL	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
SOMATROPIN	ACTIVE MOIETY	NQX9KB6PCL	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
WATER	INACTIVE INGREDIENT	059QF0KO0R	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	15
SOMATROPIN	ACTIVE INGREDIENT	NQX9KB6PCL	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SOMATROPIN	ACTIVE MOIETY	NQX9KB6PCL	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-7704	NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]	28	Current NDC, Legacy NDC, 4 package rows	20250216_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norditropin	SOMATROPIN	Novo Nordisk	1058e17c-9261-459c-a3e6-fae38d196c14	2025-07-07	Warnings, Adverse reactions	Exact identifier application number: BLA021148 ndc (product): 0169-7704

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
021148	Norditropin	somatropin	351(a)	Disc	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NQX9KB6PCL	SOMATROPIN	12629-01-5	SOMATROPIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
847348	Norditropin 10 MG in 1.5 ML Pen Injector	PSN	1058e17c-9261-459c-a3e6-fae38d196c14	30
847245	Norditropin 15 MG in 1.5 ML Pen Injector	PSN	1058e17c-9261-459c-a3e6-fae38d196c14	30
849851	Norditropin 30 MG in 3 ML Pen Injector	PSN	1058e17c-9261-459c-a3e6-fae38d196c14	30
847247	Norditropin 5 MG in 1.5 ML Pen Injector	PSN	1058e17c-9261-459c-a3e6-fae38d196c14	30
1736329	somatropin 10 MG in 1.5 ML Pen Injector	PSN	1058e17c-9261-459c-a3e6-fae38d196c14	30
847243	somatropin 15 MG in 1.5 ML Pen Injector	PSN	1058e17c-9261-459c-a3e6-fae38d196c14	30
849850	somatropin 30 MG in 3 ML Pen Injector	PSN	1058e17c-9261-459c-a3e6-fae38d196c14	30
1736262	somatropin 5 MG in 1.5 ML Pen Injector	PSN	1058e17c-9261-459c-a3e6-fae38d196c14	30
847245	1.5 ML somatropin 10 MG/ML Pen Injector [Norditropin]	SBD	1058e17c-9261-459c-a3e6-fae38d196c14	30
847247	1.5 ML somatropin 3.33 MG/ML Pen Injector [Norditropin]	SBD	1058e17c-9261-459c-a3e6-fae38d196c14	30
847348	1.5 ML somatropin 6.67 MG/ML Pen Injector [Norditropin]	SBD	1058e17c-9261-459c-a3e6-fae38d196c14	30
849851	3 ML somatropin 10 MG/ML Pen Injector [Norditropin]	SBD	1058e17c-9261-459c-a3e6-fae38d196c14	30
847243	1.5 ML somatropin 10 MG/ML Pen Injector	SCD	1058e17c-9261-459c-a3e6-fae38d196c14	30
1736262	1.5 ML somatropin 3.33 MG/ML Pen Injector	SCD	1058e17c-9261-459c-a3e6-fae38d196c14	30
1736329	1.5 ML somatropin 6.67 MG/ML Pen Injector	SCD	1058e17c-9261-459c-a3e6-fae38d196c14	30
849850	3 ML somatropin 10 MG/ML Pen Injector	SCD	1058e17c-9261-459c-a3e6-fae38d196c14	30
847348	Norditropin 10 MG per 1.5 ML Pen Injector	SY	1058e17c-9261-459c-a3e6-fae38d196c14	30
847245	Norditropin 15 MG per 1.5 ML Pen Injector	SY	1058e17c-9261-459c-a3e6-fae38d196c14	30
849851	Norditropin 30 MG per 3 ML Pen Injector	SY	1058e17c-9261-459c-a3e6-fae38d196c14	30
847247	Norditropin 5 MG per 1.5 ML Pen Injector	SY	1058e17c-9261-459c-a3e6-fae38d196c14	30
1736329	somatropin 10 MG per 1.5 ML Pen Injector	SY	1058e17c-9261-459c-a3e6-fae38d196c14	30
847243	somatropin 15 MG per 1.5 ML Pen Injector	SY	1058e17c-9261-459c-a3e6-fae38d196c14	30
849850	somatropin 30 MG per 3 ML Pen Injector	SY	1058e17c-9261-459c-a3e6-fae38d196c14	30
1736262	somatropin 5 MG per 1.5 ML Pen Injector	SY	1058e17c-9261-459c-a3e6-fae38d196c14	30
847247	Norditropin 5 MG in 1.5 ML Pen Injector	PSN	aa9d3467-a450-4b06-885a-7d834dcbddff	1
1736262	somatropin 5 MG in 1.5 ML Pen Injector	PSN	aa9d3467-a450-4b06-885a-7d834dcbddff	1
847247	1.5 ML somatropin 3.33 MG/ML Pen Injector [Norditropin]	SBD	aa9d3467-a450-4b06-885a-7d834dcbddff	1
1736262	1.5 ML somatropin 3.33 MG/ML Pen Injector	SCD	aa9d3467-a450-4b06-885a-7d834dcbddff	1
847247	Norditropin 5 MG per 1.5 ML Pen Injector	SY	aa9d3467-a450-4b06-885a-7d834dcbddff	1
1736262	somatropin 5 MG per 1.5 ML Pen Injector	SY	aa9d3467-a450-4b06-885a-7d834dcbddff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0169-7704-21	00169770421	1 SYRINGE, PLASTIC in 1 CARTON (0169-7704-21) / 1.5 mL in 1 SYRINGE, PLASTIC	2010-03-01	0000-00-00	No	No	Current
0169-7704-92	00169770492	1 SYRINGE, PLASTIC in 1 CARTON (0169-7704-92) / 1.5 mL in 1 SYRINGE, PLASTIC	2010-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Norditropin	Novo Nordisk \| Novo Nordisk A/S - Hax \| Novo Nordisk A/S - Kv	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL	30
Norditropin	Physicians Total Care, Inc.	2010-03-02	HUMAN PRESCRIPTION DRUG LABEL	1