FDA.reportPublic FDA data

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
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248288Internal RxNorm lookup
249453Internal RxNorm lookup
346494Internal RxNorm lookup
751566Internal RxNorm lookup
751568Internal RxNorm lookup
751570Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
62b01d29-90f0-45b2-a0c4-3a750ba36c8aAvailable 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

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
2022-01-28These 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
44087-0004-7Serostim1 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

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
SerostimSOMATROPINEMD Serono, Inc.62b01d29-90f0-45b2-a0c4-3a750ba36c8a2026-07-28Warnings, Adverse reactionsExact identifier
application number: BLA020604
ndc (product): 44087-0004

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020604Serostimsomatropin351(a)Rx2026-07-01

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
44087-0004-7440870004071 KIT in 1 CARTON (44087-0004-7) * 1 mL in 1 VIAL * 3.5 mL in 1 VIAL, GLASS1 kit1997-07-250000-00-00NoNoCurrent