FDA.reportPublic FDA data

Serostim

Product NDC
44087-0006
11-digit product format
440870006
Labeler code
44087
Product ID
44087-0006_83f6e6c0-4286-450b-bc91-1b9aa53ad936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
somatropin
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
EMD Serono, Inc.
Application
BLA020604
Marketing category
BLA
Marketing start
1996-08-23
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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#

Effective, Related label table
EffectiveRelated label
2022-02-02These highlights do not include all the information needed to use SEROSTIM ® safely and effectively. See full prescribing information for SEROSTIM. SEROSTIM (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987
2022-02-02These highlights do not include all the information needed to use SEROSTIM ® safely and effectively. See full prescribing information for SEROSTIM. SEROSTIM (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987
2022-02-02These highlights do not include all the information needed to use SEROSTIM ® safely and effectively. See full prescribing information for SEROSTIM. SEROSTIM (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987
2022-01-28These highlights do not include all the information needed to use SEROSTIM ® safely and effectively. See full prescribing information for SEROSTIM. SEROSTIM (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987
2022-01-28These highlights do not include all the information needed to use SEROSTIM ® safely and effectively. See full prescribing information for SEROSTIM. SEROSTIM (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987
2022-01-28These highlights do not include all the information needed to use SEROSTIM ® safely and effectively. See full prescribing information for SEROSTIM. SEROSTIM (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-0006-7Serostim1 in 1 CARTONKIT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-0006-7EA - Each44087-0006a2884808-fb69-4265-b0ce-37b4b5972d2f12012-07-24

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
44087-0006SEROSTIM (SOMATROPIN) KIT [EMD SERONO, INC.]13Current NDC, Legacy NDC, 1 package rows20220203_62b01d29-90f0-45b2-a0c4-3a750ba36c8a.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020604Serostimsomatropin351(a)Rx2026-09-01

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
44087-0006-7440870006071 KIT in 1 CARTON (44087-0006-7) * 1 mL in 1 VIAL * 1 mL in 1 VIAL1 kit1996-08-230000-00-00NoNoCurrent