ZOMACTON

Product NDC: 55566-1902
11-digit product format: 555661902
Labeler code: 55566
Product ID: 55566-1902_75cd1516-1f76-485f-8166-702c952a5167
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: somatropin
Dosage form: KIT
Route: SUBCUTANEOUS
Labeler: Ferring Pharmaceuticals Inc.
Application: BLA019774
Marketing category: BLA
Marketing start: 2018-01-30
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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	55566-1902		D	Discontinued by firm		2026-08-17
excluded package	package	55566-1902	55566-1902-1	D	Discontinued by firm		2026-08-17

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, 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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`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	55566-1902-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55566-1902-1	EA - Each	55566-1902	185810d8-0af3-45f7-8f2b-25ac53f2ccce	1	2018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SOMATROPIN	ACTIVE INGREDIENT	NQX9KB6PCL	ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]	1
somatropin	ACTIVE MOIETY	NQX9KB6PCL	ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]	1
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55566-1902	ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]	18	Legacy NDC	20240507_85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
019774	Zomacton	somatropin	351(a)	Disc	2026-08-01

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
55566-1902-1	55566190201	1 KIT in 1 CARTON (55566-1902-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 1 mL in 1 SYRINGE, PLASTIC	1 kit	2018-01-30	2022-05-31	No	No	Current