GENOTROPIN

Product NDC: 0013-2655
11-digit product format: 000132655
Labeler code: 0013
Product ID: 0013-2655_6d0c8958-367d-4767-a8fa-324203e5b360
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: somatropin
Dosage form: KIT
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: BLA020280
Marketing category: BLA
Marketing start: 1995-12-20
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
GENOTROPIN	SOMATROPIN	Pfizer Laboratories Div Pfizer Inc	ffebf88b-d257-4542-9808-74d9b7167765	2026-04-30	Warnings, Adverse reactions	Exact identifier application number: BLA020280 ndc (product): 0013-2655

Additional Listing Data#

Finished product: Yes
Brand name base: GENOTROPIN
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 25 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
241975	Internal RxNorm lookup
762830	Internal RxNorm lookup
762833	Internal RxNorm lookup
762834	Internal RxNorm lookup
762836	Internal RxNorm lookup
762837	Internal RxNorm lookup
762839	Internal RxNorm lookup
762841	Internal RxNorm lookup
762843	Internal RxNorm lookup
762846	Internal RxNorm lookup
762849	Internal RxNorm lookup
762850	Internal RxNorm lookup
762852	Internal RxNorm lookup
762857	Internal RxNorm lookup
762859	Internal RxNorm lookup
762866	Internal RxNorm lookup
762868	Internal RxNorm lookup
762873	Internal RxNorm lookup
762875	Internal RxNorm lookup
762895	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
ffebf88b-d257-4542-9808-74d9b7167765	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0013-2655-02	GENOTROPIN	7 in 1 CARTON	KIT	7		36
0013-2655-02	GENOTROPIN	1 in 1 CARTRIDGE	KIT	1		36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0013-2655-02	EA - Each	0013-2655	627ab149-899f-4aeb-bd43-531835c88dc2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SOMATROPIN	ACTIVE INGREDIENT	NQX9KB6PCL	GENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]	15
SOMATROPIN	ACTIVE MOIETY	NQX9KB6PCL	GENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]	15
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	GENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]	15
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	GENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]	15
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0013-2655	GENOTROPIN (SOMATROPIN) KIT [PFIZER LABORATORIES DIV PFIZER INC]	34	Current NDC, Legacy NDC, 2 package rows	20250221_ffebf88b-d257-4542-9808-74d9b7167765.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
020280	Genotropin	somatropin	351(a)	Disc	2026-06-01

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
762833	Genotropin 0.2 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762836	Genotropin 0.4 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762839	Genotropin 0.6 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762843	Genotropin 0.8 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762875	Genotropin 1 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762849	Genotropin 1.2 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762852	Genotropin 1.4 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762859	Genotropin 1.6 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762868	Genotropin 1.8 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
996559	Genotropin 12 MG in 1 ML Cartridge	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762897	Genotropin 2 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
763489	Genotropin 5 MG in 1 ML Cartridge	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762830	somatropin 0.2 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762834	somatropin 0.4 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762837	somatropin 0.6 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762841	somatropin 0.8 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762873	somatropin 1 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762846	somatropin 1.2 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762850	somatropin 1.4 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762857	somatropin 1.6 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762866	somatropin 1.8 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
996558	somatropin 12 MG in 1 ML Cartridge	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762895	somatropin 2 MG in 0.25 ML Prefilled Syringe	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
763488	somatropin 5 MG in 1 ML Cartridge	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
241975	somatropin 5 MG/ML Injectable Solution	PSN	ffebf88b-d257-4542-9808-74d9b7167765	36
762833	0.25 ML somatropin 0.8 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762836	0.25 ML somatropin 1.6 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762839	0.25 ML somatropin 2.4 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762843	0.25 ML somatropin 3.2 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762875	0.25 ML somatropin 4 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762849	0.25 ML somatropin 4.8 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762852	0.25 ML somatropin 5.6 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762859	0.25 ML somatropin 6.4 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762868	0.25 ML somatropin 7.2 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762897	0.25 ML somatropin 8 MG/ML Prefilled Syringe [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
996559	1 ML somatropin 12 MG/ML Cartridge [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
763489	1 ML somatropin 5 MG/ML Cartridge [Genotropin]	SBD	ffebf88b-d257-4542-9808-74d9b7167765	36
762830	0.25 ML somatropin 0.8 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762834	0.25 ML somatropin 1.6 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762837	0.25 ML somatropin 2.4 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762841	0.25 ML somatropin 3.2 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762873	0.25 ML somatropin 4 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762846	0.25 ML somatropin 4.8 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762850	0.25 ML somatropin 5.6 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762857	0.25 ML somatropin 6.4 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762866	0.25 ML somatropin 7.2 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762895	0.25 ML somatropin 8 MG/ML Prefilled Syringe	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
996558	1 ML somatropin 12 MG/ML Cartridge	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
763488	1 ML somatropin 5 MG/ML Cartridge	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
241975	somatropin 5 MG/ML Injectable Solution	SCD	ffebf88b-d257-4542-9808-74d9b7167765	36
762833	Genotropin 0.2 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762836	Genotropin 0.4 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762839	Genotropin 0.6 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762843	Genotropin 0.8 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762875	Genotropin 1 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762849	Genotropin 1.2 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762852	Genotropin 1.4 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762859	Genotropin 1.6 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762868	Genotropin 1.8 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
996559	Genotropin 12 MG per 1 ML Cartridge	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762897	Genotropin 2 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
763489	Genotropin 5 MG per 1 ML Cartridge	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762833	Genotropin MiniQuick 0.2 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762836	Genotropin MiniQuick 0.4 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762839	Genotropin MiniQuick 0.6 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762843	Genotropin MiniQuick 0.8 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762875	Genotropin MiniQuick 1 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762849	Genotropin MiniQuick 1.2 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762852	Genotropin MiniQuick 1.4 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762859	Genotropin MiniQuick 1.6 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762868	Genotropin MiniQuick 1.8 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762897	Genotropin MiniQuick 2 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762830	somatropin 0.2 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762834	somatropin 0.4 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762837	somatropin 0.6 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762841	somatropin 0.8 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762873	somatropin 1 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762846	somatropin 1.2 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762850	somatropin 1.4 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36
762857	somatropin 1.6 MG per 0.25 ML Prefilled Syringe	SY	ffebf88b-d257-4542-9808-74d9b7167765	36

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0013-2655-02	00013265502	7 CARTRIDGE in 1 CARTON (0013-2655-02) / 1 KIT in 1 CARTRIDGE	7 cartridge	1995-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GENOTROPIN	Pfizer Laboratories Div Pfizer Inc \| Pfizer Health AB	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	36