depo-testosterone

Generic: testosterone cypionate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name depo-testosterone
Generic Name testosterone cypionate
Labeler asclemed usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

testosterone cypionate 100 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-425
Product ID 76420-425_3d534b61-bcc6-9c44-e063-6294a90a1b6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085635
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 1979-07-25

Pharmacologic Class

Classes
androgen receptor agonists [moa] androgen [epc] androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420425
Hyphenated Format 76420-425

Supplemental Identifiers

RxCUI
835829 835831
UNII
M0XW1UBI14

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name depo-testosterone (source: ndc)
Generic Name testosterone cypionate (source: ndc)
Application Number ANDA085635 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (76420-425-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

76420-425-10 1 VIAL in 1 CARTON (76420-425-10) / 10 mL in 1 VIAL

Ingredients (1)

testosterone cypionate (100 mg/mL)

Linked Drug Pages (1)

Depo-Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "3d534b61-bcc6-9c44-e063-6294a90a1b6b", "openfda": {"unii": ["M0XW1UBI14"], "rxcui": ["835829", "835831"], "spl_set_id": ["2f72be32-ede6-44d9-88a0-0653b53a3e47"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (76420-425-10)  / 10 mL in 1 VIAL", "package_ndc": "76420-425-10", "marketing_start_date": "20250808"}], "brand_name": "Depo-Testosterone", "product_id": "76420-425_3d534b61-bcc6-9c44-e063-6294a90a1b6b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "76420-425", "dea_schedule": "CIII", "generic_name": "testosterone cypionate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Depo-Testosterone", "active_ingredients": [{"name": "TESTOSTERONE CYPIONATE", "strength": "100 mg/mL"}], "application_number": "ANDA085635", "marketing_category": "ANDA", "marketing_start_date": "19790725", "listing_expiration_date": "20261231"}