Nutropin AQ NuSpin 5

Product NDC
50242-075
11-digit product format
502420075
Labeler code
50242
Product ID
50242-075_4c3b5898-d8f8-4dea-b77a-8a88d0419327
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
somatropin
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA020522
Marketing category
BLA
Marketing start
1995-12-29
Marketing end
0000-00-00
Substance
SOMATROPIN
Active strength
5 mg/2mL
Pharmacologic classes
Recombinant Human Growth Hormone [EPC],Human Growth Hormone [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-075-01Nutropin AQ NuSpin 52 mL in 1 CARTRIDGEINJECTION, SOLUTION218
50242-075-01Nutropin AQ NuSpin 51 in 1 CARTONINJECTION, SOLUTION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-075-01ML - Milliliter50242-07502ba3af2-9dbc-4fb1-a2df-82dd210efa4e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOMATROPINACTIVE INGREDIENTNQX9KB6PCLNUTROPIN AQ PEN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ PEN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 5 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION [GENENTECH, INC.]4
SOMATROPINACTIVE MOIETYNQX9KB6PCLNUTROPIN AQ PEN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ PEN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 5 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION [GENENTECH, INC.]4
PHENOLINACTIVE INGREDIENT339NCG44TVNUTROPIN AQ PEN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ PEN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 5 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION [GENENTECH, INC.]4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNUTROPIN AQ PEN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ PEN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 5 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION [GENENTECH, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNUTROPIN AQ PEN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ PEN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 5 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION [GENENTECH, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNUTROPIN AQ PEN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ PEN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 5 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 10 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 20 (SOMATROPIN (RDNA ORIGIN)) INJECTION, SOLUTION [GENENTECH, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-075NUTROPIN AQ NUSPIN 5 (SOMATROPIN) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 10 (SOMATROPIN) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 20 (SOMATROPIN) INJECTION, SOLUTION [GENENTECH, INC.]17Legacy NDC, 2 package rows20241122_139d2038-e6a9-4ab1-ab00-aa7d8aa8df5f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-075-01502420075011 CARTRIDGE in 1 CARTON (50242-075-01) > 2 mL in 1 CARTRIDGE1 cartridge1995-12-290000-00-00NoNoCurrent