FDA.reportPublic FDA data

Omnitrope

Product NDC
0781-3001
11-digit product format
007813001
Labeler code
0781
Product ID
0781-3001_22eba20c-aa55-440d-846e-a1235440fecb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Somatropin
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc
Application
BLA021426
Marketing category
BLA
Marketing start
2006-05-30
Substance
SOMATROPIN
Active strength
5 mg/1.5mL
Pharmacologic classes
Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOMATROPIN5 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NQX9KB6PCLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
241975Internal RxNorm lookup
645884Internal RxNorm lookup
854302Internal RxNorm lookup
864110Internal RxNorm lookup
1736267Internal RxNorm lookup
1736337Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58d84ffa-4056-4e36-ad67-7bd4aef444a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3001-07Omnitrope1.5 mL in 1 CARTRIDGEINJECTION, SOLUTION1.536
0781-3001-07Omnitrope1 in 1 CARTONINJECTION, SOLUTION136
0781-3001-26Omnitrope5 in 1 CARTONINJECTION, SOLUTION536
0781-3001-26Omnitrope1.5 mL in 1 CARTRIDGEINJECTION, SOLUTION1.536

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3001-07ML - Milliliter0781-300123c2caad-ddfe-43ba-aa26-ff69600744eb12012-07-24
0781-3001-26ML - Milliliter0781-3001825098be-1aa4-46f7-8651-fee0955a9afe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOMATROPINACTIVE INGREDIENTNQX9KB6PCLOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
SOMATROPINACTIVE MOIETYNQX9KB6PCLOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
GLYCINEINACTIVE INGREDIENTTE7660XO1COMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
PHENOLINACTIVE INGREDIENT339NCG44TVOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
WATERINACTIVE INGREDIENT059QF0KO0ROMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3001OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]34Current NDC, Legacy NDC, 4 package rows20241215_58d84ffa-4056-4e36-ad67-7bd4aef444a5.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
OmnitropeSOMATROPINSandoz Inc58d84ffa-4056-4e36-ad67-7bd4aef444a52025-07-10Warnings, Adverse reactionsExact identifier
application number: BLA021426
ndc (product): 0781-3001

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021426Omnitropesomatropin351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854302Omnitrope 10 MG in 1.5 ML CartridgePSN58d84ffa-4056-4e36-ad67-7bd4aef444a536
864110Omnitrope 5 MG in 1.5 ML CartridgePSN58d84ffa-4056-4e36-ad67-7bd4aef444a536
645884Omnitrope 5 MG/ML Injectable SolutionPSN58d84ffa-4056-4e36-ad67-7bd4aef444a536
1736337somatropin 10 MG in 1.5 ML CartridgePSN58d84ffa-4056-4e36-ad67-7bd4aef444a536
1736267somatropin 5 MG in 1.5 ML CartridgePSN58d84ffa-4056-4e36-ad67-7bd4aef444a536
241975somatropin 5 MG/ML Injectable SolutionPSN58d84ffa-4056-4e36-ad67-7bd4aef444a536
8641101.5 ML somatropin 3.3 MG/ML Cartridge [Omnitrope]SBD58d84ffa-4056-4e36-ad67-7bd4aef444a536
8543021.5 ML somatropin 6.67 MG/ML Cartridge [Omnitrope]SBD58d84ffa-4056-4e36-ad67-7bd4aef444a536
645884somatropin 5 MG/ML Injectable Solution [Omnitrope]SBD58d84ffa-4056-4e36-ad67-7bd4aef444a536
17362671.5 ML somatropin 3.3 MG/ML CartridgeSCD58d84ffa-4056-4e36-ad67-7bd4aef444a536
17363371.5 ML somatropin 6.67 MG/ML CartridgeSCD58d84ffa-4056-4e36-ad67-7bd4aef444a536
241975somatropin 5 MG/ML Injectable SolutionSCD58d84ffa-4056-4e36-ad67-7bd4aef444a536
854302Omnitrope 10 MG per 1.5 ML CartridgeSY58d84ffa-4056-4e36-ad67-7bd4aef444a536
864110Omnitrope 5 MG per 1.5 ML CartridgeSY58d84ffa-4056-4e36-ad67-7bd4aef444a536
645884Omnitrope 5 MG/ML Injectable SolutionSY58d84ffa-4056-4e36-ad67-7bd4aef444a536
1736337somatropin 10 MG per 1.5 ML CartridgeSY58d84ffa-4056-4e36-ad67-7bd4aef444a536
1736267somatropin 5 MG per 1.5 ML CartridgeSY58d84ffa-4056-4e36-ad67-7bd4aef444a536

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3001-07007813001071 CARTRIDGE in 1 CARTON (0781-3001-07) / 1.5 mL in 1 CARTRIDGE1 cartridge2006-05-300000-00-00NoNoCurrent
0781-3001-26007813001265 CARTRIDGE in 1 CARTON (0781-3001-26) / 1.5 mL in 1 CARTRIDGE5 cartridge2006-05-300000-00-00NoNoCurrent