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Depo-Testosterone

Depo-Testosteronetestosterone cypionate injection, USP    CIII

Approved
Approval ID

837570cb-8a33-4129-ad41-bead378d9987

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 26, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

testosterone cypionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-0216
Application NumberANDA085635
Product Classification
M
Marketing Category
C73584
G
Generic Name
testosterone cypionate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 12, 2011
FDA Product Classification

INGREDIENTS (4)

TESTOSTERONE CYPIONATEActive
Quantity: 200 mg in 1 mL
Code: M0XW1UBI14
Classification: ACTIB
BENZYL BENZOATEInactive
Quantity: 0.2 mL in 1 mL
Code: N863NB338G
Classification: IACT
COTTONSEED OILInactive
Quantity: 560 mg in 1 mL
Code: H3E878020N
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9.45 mg in 1 mL
Code: LKG8494WBH
Classification: IACT

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Depo-Testosterone - FDA Drug Approval Details