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 Identifiers#

Field, Values table
Field	Values
Unii	NQX9KB6PCL
Rxcui	847243, 847245, 847247, 847348, 849850, 849851, 1736262, 1736329

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

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

Norditropin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#