NDC 0591-3221

Testosterone Enanthate

Testosterone Enanthate

Testosterone Enanthate is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Testosterone Enanthate.

• Product ID: 0591-3221_1693f744-45f0-44ee-81c9-4542cde6e3b7
• NDC: 0591-3221
• Product Type: Human Prescription Drug
• Proprietary Name: Testosterone Enanthate
• Generic Name: Testosterone Enanthate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2011-05-04
• Marketing End Date: 2019-12-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA085598
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: TESTOSTERONE ENANTHATE
• Active Ingredient Strength: 200 mg/mL
• Pharm Classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: N

Packaging

NDC 0591-3221-26

1 VIAL, MULTI-DOSE in 1 CARTON (0591-3221-26) > 5 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2011-05-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-3221-26 [00591322126]

Testosterone Enanthate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA085598
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-05-04
• Marketing End Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE ENANTHATE	200 mg/mL

OpenFDA Data

• SPL SET ID: a0af5e80-8d01-4aa9-9f33-926735fdd38a
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 7Z6522T8N9
• RxNorm Concept Unique ID - RxCUI:
  • 835809

Pharmacological Class

• Androgen [EPC]
• Androgen Receptor Agonists [MoA]
• Androstanes [CS]

NDC Crossover Matching brand name "Testosterone Enanthate" or generic name "Testosterone Enanthate"

NDC	Brand Name	Generic Name
0143-9750	TESTOSTERONE ENANTHATE	TESTOSTERONE ENANTHATE
0591-3221	Testosterone Enanthate	Testosterone Enanthate
54436-200	XYOSTED	testosterone enanthate
54436-250	XYOSTED	testosterone enanthate
54436-275	XYOSTED	testosterone enanthate