FDA.reportPublic FDA data

ZOMACTON

Product NDC
55566-1902
Requested package NDC
55566-1902-1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55566-190255566-1902-1DDiscontinued by firm2026-09-14

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-1902-1EA - Each55566-1902185810d8-0af3-45f7-8f2b-25ac53f2ccce12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOMATROPINACTIVE INGREDIENTNQX9KB6PCLZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]1
somatropinACTIVE MOIETYNQX9KB6PCLZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]1
METACRESOLINACTIVE INGREDIENTGGO4Y809LOZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-1902ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]18Legacy NDC20240507_85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOMACTONSOMATROPINFerring Pharmaceuticals Inc.85ba081b-bee0-4a9a-aa0f-ae5b5e9a08862026-04-20Warnings, Adverse reactionsExact identifier
application number: BLA019774

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019774Zomactonsomatropin351(a)Disc2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-1902-1555661902011 KIT in 1 CARTON (55566-1902-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 1 mL in 1 SYRINGE, PLASTIC1 kit2018-01-302022-05-31NoNoCurrent