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Testosterone Cypionate

Testosterone Cypionate Injection C-III

Approved
Approval ID

3602f307-19c3-4f09-a3e3-98c10a19ec28

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 16, 2021

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-4446
Application NumberANDA201720
Product Classification
M
Marketing Category
C73584
G
Generic Name
Testosterone Cypionate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 3, 2020
FDA Product Classification

INGREDIENTS (4)

BENZYL BENZOATEInactive
Quantity: 0.2 mL in 1 mL
Code: N863NB338G
Classification: IACT
TESTOSTERONE CYPIONATEActive
Quantity: 200 mg in 1 mL
Code: M0XW1UBI14
Classification: ACTIB
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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Testosterone Cypionate - FDA Drug Approval Details