saizenprep

Product NDC: 44087-0016
11-digit product format: 440870016
Labeler code: 44087
Product ID: 44087-0016_64751965-e0af-4687-8682-49411ebeff77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: somatropin
Dosage form: KIT
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: EMD Serono, Inc.
Application: BLA019764
Marketing category: BLA
Marketing start: 2017-01-17
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	44087-0016		D	Discontinued by firm		2026-08-10
excluded package	package	44087-0016	44087-0016-1	D	Discontinued by firm		2026-08-10

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	44087-0016-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	44087-0016-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	44087-0016-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	44087-0016-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	44087-0016-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	44087-0016-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	44087-0016-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	44087-0016-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	44087-0016-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	44087-0016-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	44087-0016-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	44087-0016-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44087-0016-1	2022-02-02	C162847	48780-1	d6a99b39-5512-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use SAIZEN ® safely and effectively. See full prescribing information for SAIZEN. SAIZEN (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987
44087-0016-1	2022-01-28	C162847	48780-1	d6a99b39-5512-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use SAIZEN ® safely and effectively. See full prescribing information for SAIZEN. SAIZEN (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44087-0016-1	EA - Each	44087-0016	87a2efa9-840e-4853-9a24-804be394dcfd	1	2017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SOMATROPIN	ACTIVE INGREDIENT	NQX9KB6PCL	SAIZEN (SOMATROPIN) KIT SAIZEN CLICKEASY (SOMATROPIN) KIT [EMD SERONO, INC.]	7
SOMATROPIN	ACTIVE MOIETY	NQX9KB6PCL	SAIZEN (SOMATROPIN) KIT SAIZEN CLICKEASY (SOMATROPIN) KIT [EMD SERONO, INC.]	7
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	SAIZEN (SOMATROPIN) KIT SAIZEN CLICKEASY (SOMATROPIN) KIT [EMD SERONO, INC.]	7
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	SAIZEN (SOMATROPIN) KIT SAIZEN CLICKEASY (SOMATROPIN) KIT [EMD SERONO, INC.]	7
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	SAIZEN (SOMATROPIN) KIT SAIZEN CLICKEASY (SOMATROPIN) KIT [EMD SERONO, INC.]	7
SUCROSE	INACTIVE INGREDIENT	C151H8M554	SAIZEN (SOMATROPIN) KIT SAIZEN CLICKEASY (SOMATROPIN) KIT [EMD SERONO, INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	SAIZEN (SOMATROPIN) KIT SAIZEN CLICKEASY (SOMATROPIN) KIT [EMD SERONO, INC.]	7

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
019764	Saizen	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44087-0016-1	44087001601	1 KIT in 1 CARTON (44087-0016-1) * 1.51 mL in 1 VIAL, GLASS * 1.51 mL in 1 CARTRIDGE	1 kit	2017-01-17	0000-00-00	No	No	Current