FDA.reportPublic FDA data

ZOMACTON

Product NDC
55566-1901
11-digit product format
555661901
Labeler code
55566
Product ID
55566-1901_31737317-181b-48ea-b779-4bdac8952601
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
somatropin
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Ferring Pharmaceuticals Inc.
Application
BLA019774
Marketing category
BLA
Marketing start
2015-05-07
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
241975Internal RxNorm lookup
284989Internal RxNorm lookup
1648160Internal RxNorm lookup
1648162Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-1901-1ZOMACTON1 in 1 CARTONKIT123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-1901-1EA - Each55566-19011d9292ed-0895-4d1c-ab8c-8cb994961eac12015-06-09

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
55566-1901ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 1 package rows20240507_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-ae5b5e9a08862025-11-14Warnings, Adverse reactionsExact identifier
application number: BLA019774
ndc (product): 55566-1901

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019774Zomactonsomatropin351(a)Disc2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284989somatropin 10 MG/ML Injectable SolutionPSN85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
241975somatropin 5 MG/ML Injectable SolutionPSN85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
1648160ZOMACTON 10 MG/ML Injectable SolutionPSN85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
1648162ZOMACTON 5 MG/ML Injectable SolutionPSN85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
1648160somatropin 10 MG/ML Injectable Solution [Zomacton]SBD85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
1648162somatropin 5 MG/ML Injectable Solution [Zomacton]SBD85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
284989somatropin 10 MG/ML Injectable SolutionSCD85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
241975somatropin 5 MG/ML Injectable SolutionSCD85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
1648160Zomacton 10 MG/ML Injectable SolutionSY85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623
1648162Zomacton 5 MG/ML Injectable SolutionSY85ba081b-bee0-4a9a-aa0f-ae5b5e9a088623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-1901-1555661901011 KIT in 1 CARTON (55566-1901-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 1 mL in 1 SYRINGE, PLASTIC1 kit2015-05-070000-00-00NoNoCurrent