FDA.reportPublic FDA data

Omnitrope

Product NDC
0781-4004
11-digit product format
007814004
Labeler code
0781
Product ID
0781-4004_22eba20c-aa55-440d-846e-a1235440fecb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Somatropin
Dosage form
KIT
Labeler
Sandoz Inc
Application
BLA021426
Marketing category
BLA
Marketing start
2006-05-30
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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNQX9KB6PCL
Rxcui241975, 645884, 854302, 864110, 1736267, 1736337

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
0781-4004-36Omnitrope1 in 1 CARTONKIT136
0781-4014-71Omnitrope1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1 mL5.8 mg in 1mL36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-4004-36EA - Each0781-400426bd4957-c959-44d1-8e24-edb195dc129f12012-07-24

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
0781-4004OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]34Current NDC, Legacy NDC, 2 package rows20241215_58d84ffa-4056-4e36-ad67-7bd4aef444a5.zip

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
0781-4004-36007814004361 KIT in 1 CARTON (0781-4004-36) * 1 mL in 1 VIAL (0781-4014-71) * 1.14 mL in 1 VIAL (0781-4024-72) 1 kit2006-05-300000-00-00NoNoCurrent
0781-4014-71007814014711 mL in 1 VIAL1 mlHistorical