FDA.reportPublic FDA data

HUMATROPE

Product NDC
0002-8148
11-digit product format
000028148
Labeler code
0002
Product ID
0002-8148_65052345-9f7f-4580-8cff-1e61a421843c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Somatropin
Dosage form
KIT
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA019640
Marketing category
BLA
Marketing start
2006-01-27
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582969Internal RxNorm lookup
582971Internal RxNorm lookup
582974Internal RxNorm lookup
582976Internal RxNorm lookup
729232Internal RxNorm lookup
729234Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a774e1ae-3997-49ee-8b0e-99a2b315d409Available 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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-7555-01HUMATROPE2.88 mL in 1 CARTRIDGEINJECTION, POWDER, FOR SOLUTION2.88 mL12 mg in 2.88mL44
0002-8148-01HUMATROPE1 in 1 CARTONKIT144
0002-8148-01HUMATROPE1 in 1 TRAYKIT144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8148-01EA - Each0002-8148c2698c4b-a07a-4e2b-aa0c-1a93f6af4ad412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SomatropinACTIVE INGREDIENTNQX9KB6PCLHUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]24
SomatropinACTIVE MOIETYNQX9KB6PCLHUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]24
glycineINACTIVE INGREDIENTTE7660XO1CHUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]24
mannitolINACTIVE INGREDIENT3OWL53L36AHUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]24
phosphoric acidINACTIVE INGREDIENTE4GA8884NNHUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]24
sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]24
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74HUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8148HUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]41Current NDC, Legacy NDC, 3 package rows20241212_a774e1ae-3997-49ee-8b0e-99a2b315d409.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
HUMATROPESOMATROPINEli Lilly and Companya774e1ae-3997-49ee-8b0e-99a2b315d4092025-11-25Warnings, Adverse reactionsExact identifier
application number: BLA019640
ndc (product): 0002-8148

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019640Humatropesomatropin351(a)Disc2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582971Humatrope 12 MG CartridgePSNa774e1ae-3997-49ee-8b0e-99a2b315d40944
582976Humatrope 24 MG CartridgePSNa774e1ae-3997-49ee-8b0e-99a2b315d40944
729234Humatrope 6 MG CartridgePSNa774e1ae-3997-49ee-8b0e-99a2b315d40944
582969somatropin 12 MG CartridgePSNa774e1ae-3997-49ee-8b0e-99a2b315d40944
582974somatropin 24 MG CartridgePSNa774e1ae-3997-49ee-8b0e-99a2b315d40944
729232somatropin 6 MG CartridgePSNa774e1ae-3997-49ee-8b0e-99a2b315d40944
582971somatropin 12 MG Cartridge [Humatrope]SBDa774e1ae-3997-49ee-8b0e-99a2b315d40944
582976somatropin 24 MG Cartridge [Humatrope]SBDa774e1ae-3997-49ee-8b0e-99a2b315d40944
729234somatropin 6 MG Cartridge [Humatrope]SBDa774e1ae-3997-49ee-8b0e-99a2b315d40944
582969somatropin 12 MG CartridgeSCDa774e1ae-3997-49ee-8b0e-99a2b315d40944
582974somatropin 24 MG CartridgeSCDa774e1ae-3997-49ee-8b0e-99a2b315d40944
729232somatropin 6 MG CartridgeSCDa774e1ae-3997-49ee-8b0e-99a2b315d40944
582971Humatrope 12 MG CartridgeSYa774e1ae-3997-49ee-8b0e-99a2b315d40944
582976Humatrope 24 MG CartridgeSYa774e1ae-3997-49ee-8b0e-99a2b315d40944
729234Humatrope 6 MG CartridgeSYa774e1ae-3997-49ee-8b0e-99a2b315d40944

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-7555-01000027555012.88 mL in 1 CARTRIDGE2.88 mlHistorical
0002-8148-01000028148011 TRAY in 1 CARTON (0002-8148-01) / 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7555-01) * 2.88 mL in 1 SYRINGE (0002-7619-01) 1 tray2006-01-270000-00-00NoNoCurrent