Serostim

Product NDC
44087-0004
11-digit product format
440870004
Labeler code
44087
Product ID
44087-0004_40a8b335-3874-4c7c-a332-ae94dd7a48e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
somatropin
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
EMD Serono, Inc.
Application
BLA020604
Marketing category
BLA
Marketing start
1997-07-25
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Serostim
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui248288, 249453, 346494, 751566, 751568, 751570

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-0004-7Serostim1 in 1 CARTONKIT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-0004-7EA - Each44087-00048075d7c7-99d9-4ac8-bed2-13cf3931416012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOMATROPINACTIVE INGREDIENTNQX9KB6PCLSEROSTIM (SOMATROPIN) KIT [EMD SERONO, INC.]6
SOMATROPINACTIVE MOIETYNQX9KB6PCLSEROSTIM (SOMATROPIN) KIT [EMD SERONO, INC.]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSEROSTIM (SOMATROPIN) KIT [EMD SERONO, INC.]6
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNSEROSTIM (SOMATROPIN) KIT [EMD SERONO, INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554SEROSTIM (SOMATROPIN) KIT [EMD SERONO, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RSEROSTIM (SOMATROPIN) KIT [EMD SERONO, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-0004SEROSTIM (SOMATROPIN) KIT [EMD SERONO, INC.]13Current NDC, Legacy NDC, 1 package rows20220203_62b01d29-90f0-45b2-a0c4-3a750ba36c8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751568Serostim 5 MG InjectionPSN62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
751570Serostim 6 MG InjectionPSN62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
751566Serostim 8 MG/ML Injectable SolutionPSN62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
346494somatropin 5 MG InjectionPSN62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
249453somatropin 6 MG InjectionPSN62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
248288somatropin 8 MG/ML Injectable SolutionPSN62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
751568somatropin 5 MG Injection [Serostim]SBD62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
751570somatropin 6 MG Injection [Serostim]SBD62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
751566somatropin 8 MG/ML Injectable Solution [Serostim]SBD62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
346494somatropin 5 MG InjectionSCD62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
249453somatropin 6 MG InjectionSCD62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
248288somatropin 8 MG/ML Injectable SolutionSCD62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
751568Serostim 5 MG InjectionSY62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
751570Serostim 6 MG InjectionSY62b01d29-90f0-45b2-a0c4-3a750ba36c8a13
751566Serostim 8 MG/ML Injectable SolutionSY62b01d29-90f0-45b2-a0c4-3a750ba36c8a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44087-0004-7440870004071 KIT in 1 CARTON (44087-0004-7) * 1 mL in 1 VIAL * 3.5 mL in 1 VIAL, GLASS1 kit1997-07-250000-00-00NoNoCurrent