Testosterone Cypionate

Product NDC
0591-4128
11-digit product format
005914128
Labeler code
0591
Product ID
0591-4128_29a2173d-d9b2-467b-94ea-a0041e8c951f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Actavis Pharma, Inc.
Application
ANDA091244
Marketing category
ANDA
Marketing start
2015-03-05
Marketing end
0000-00-00
Substance
TESTOSTERONE CYPIONATE
Active strength
200 mg/mL
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4128-79ML - Milliliter0591-41286cafa2f2-48ec-4ed7-8979-47a4ccd3575112015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONE CYPIONATEACTIVE INGREDIENTM0XW1UBI14TESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]6
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]6
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GTESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]6
COTTONSEED OILINACTIVE INGREDIENTH3E878020NTESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4128TESTOSTERONE CYPIONATE INJECTION [ACTAVIS PHARMA, INC.]13Legacy NDC20230420_d7b57b68-dca6-4df2-b3f2-7017d7b69f17.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-4128-790059141287910 mL in 1 VIAL (0591-4128-79) 10 ml2015-03-050000-00-00NoNoCurrent