FDA.reportPublic FDA data

GENOTROPIN

Product NDC
0013-2626
11-digit product format
000132626
Labeler code
0013
Product ID
0013-2626_6d0c8958-367d-4767-a8fa-324203e5b360
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
somatropin
Dosage form
KIT
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA020280
Marketing category
BLA
Marketing start
1995-12-20
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui241975, 762830, 762833, 762834, 762836, 762837, 762839, 762841, 762843, 762846, 762849, 762850, 762852, 762857, 762859, 762866, 762868, 762873, 762875, 762895

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
0013-2626-81GENOTROPIN1 in 1 CARTONKIT136
0013-2626-81GENOTROPIN1 in 1 CARTRIDGEKIT136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-2626-81EA - Each0013-2626a5abe067-e3d6-4212-8fa8-05513472946112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOMATROPINACTIVE INGREDIENTNQX9KB6PCLGENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]15
SOMATROPINACTIVE MOIETYNQX9KB6PCLGENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]15
GLYCINEINACTIVE INGREDIENTTE7660XO1CGENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]15
MANNITOLINACTIVE INGREDIENT3OWL53L36AGENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]15
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUGENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]15
WATERINACTIVE INGREDIENT059QF0KO0RGENOTROPIN (SOMATROPIN) KIT [PHARMACIA AND UPJOHN COMPANY]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0013-2626GENOTROPIN (SOMATROPIN) KIT [PFIZER LABORATORIES DIV PFIZER INC]34Current NDC, Legacy NDC, 2 package rows20250221_ffebf88b-d257-4542-9808-74d9b7167765.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762833Genotropin 0.2 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762836Genotropin 0.4 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762839Genotropin 0.6 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762843Genotropin 0.8 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762875Genotropin 1 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762849Genotropin 1.2 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762852Genotropin 1.4 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762859Genotropin 1.6 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762868Genotropin 1.8 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
996559Genotropin 12 MG in 1 ML CartridgePSNffebf88b-d257-4542-9808-74d9b716776536
762897Genotropin 2 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
763489Genotropin 5 MG in 1 ML CartridgePSNffebf88b-d257-4542-9808-74d9b716776536
762830somatropin 0.2 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762834somatropin 0.4 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762837somatropin 0.6 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762841somatropin 0.8 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762873somatropin 1 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762846somatropin 1.2 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762850somatropin 1.4 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762857somatropin 1.6 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
762866somatropin 1.8 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
996558somatropin 12 MG in 1 ML CartridgePSNffebf88b-d257-4542-9808-74d9b716776536
762895somatropin 2 MG in 0.25 ML Prefilled SyringePSNffebf88b-d257-4542-9808-74d9b716776536
763488somatropin 5 MG in 1 ML CartridgePSNffebf88b-d257-4542-9808-74d9b716776536
241975somatropin 5 MG/ML Injectable SolutionPSNffebf88b-d257-4542-9808-74d9b716776536
7628330.25 ML somatropin 0.8 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628360.25 ML somatropin 1.6 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628390.25 ML somatropin 2.4 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628430.25 ML somatropin 3.2 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628750.25 ML somatropin 4 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628490.25 ML somatropin 4.8 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628520.25 ML somatropin 5.6 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628590.25 ML somatropin 6.4 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628680.25 ML somatropin 7.2 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628970.25 ML somatropin 8 MG/ML Prefilled Syringe [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
9965591 ML somatropin 12 MG/ML Cartridge [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7634891 ML somatropin 5 MG/ML Cartridge [Genotropin]SBDffebf88b-d257-4542-9808-74d9b716776536
7628300.25 ML somatropin 0.8 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628340.25 ML somatropin 1.6 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628370.25 ML somatropin 2.4 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628410.25 ML somatropin 3.2 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628730.25 ML somatropin 4 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628460.25 ML somatropin 4.8 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628500.25 ML somatropin 5.6 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628570.25 ML somatropin 6.4 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628660.25 ML somatropin 7.2 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
7628950.25 ML somatropin 8 MG/ML Prefilled SyringeSCDffebf88b-d257-4542-9808-74d9b716776536
9965581 ML somatropin 12 MG/ML CartridgeSCDffebf88b-d257-4542-9808-74d9b716776536
7634881 ML somatropin 5 MG/ML CartridgeSCDffebf88b-d257-4542-9808-74d9b716776536
241975somatropin 5 MG/ML Injectable SolutionSCDffebf88b-d257-4542-9808-74d9b716776536
762833Genotropin 0.2 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762836Genotropin 0.4 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762839Genotropin 0.6 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762843Genotropin 0.8 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762875Genotropin 1 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762849Genotropin 1.2 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762852Genotropin 1.4 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762859Genotropin 1.6 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762868Genotropin 1.8 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
996559Genotropin 12 MG per 1 ML CartridgeSYffebf88b-d257-4542-9808-74d9b716776536
762897Genotropin 2 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
763489Genotropin 5 MG per 1 ML CartridgeSYffebf88b-d257-4542-9808-74d9b716776536
762833Genotropin MiniQuick 0.2 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762836Genotropin MiniQuick 0.4 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762839Genotropin MiniQuick 0.6 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762843Genotropin MiniQuick 0.8 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762875Genotropin MiniQuick 1 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762849Genotropin MiniQuick 1.2 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762852Genotropin MiniQuick 1.4 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762859Genotropin MiniQuick 1.6 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762868Genotropin MiniQuick 1.8 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762897Genotropin MiniQuick 2 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762830somatropin 0.2 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762834somatropin 0.4 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762837somatropin 0.6 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762841somatropin 0.8 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762873somatropin 1 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762846somatropin 1.2 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762850somatropin 1.4 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536
762857somatropin 1.6 MG per 0.25 ML Prefilled SyringeSYffebf88b-d257-4542-9808-74d9b716776536

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0013-2626-81000132626811 CARTRIDGE in 1 CARTON (0013-2626-81) / 1 KIT in 1 CARTRIDGE1 cartridge1995-12-200000-00-00NoNoCurrent