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 Identifiers#

Field, Values table
FieldValues
Rxcui241975, 284989, 1648160, 1648162

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

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