testosterone cypionate

Generic: testosterone cypionate

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone cypionate
Generic Name testosterone cypionate
Labeler padagis us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

testosterone cypionate 200 mg/mL

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-0827
Product ID 0574-0827_aa3130c8-5ef7-4fcc-8478-7c2dd9973fbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091244
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2014-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05740827
Hyphenated Format 0574-0827

Supplemental Identifiers

RxCUI
835840 2047882
UNII
M0XW1UBI14

Packaging Origin

Original Packager
true

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 testosterone cypionate (source: ndc)
Generic Name testosterone cypionate (source: ndc)
Application Number ANDA091244 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS
  • 1 VIAL, GLASS in 1 CARTON (0574-0827-10) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

0574-0827-01 1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS 0574-0827-10 1 VIAL, GLASS in 1 CARTON (0574-0827-10) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

testosterone cypionate (200 mg/mL)

Linked Drug Pages (1)

Testosterone Cypionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "aa3130c8-5ef7-4fcc-8478-7c2dd9973fbe", "openfda": {"unii": ["M0XW1UBI14"], "rxcui": ["835840", "2047882"], "spl_set_id": ["e3e2da65-4b2a-4210-a6ff-cc08c8567381"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0574-0827-01)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "0574-0827-01", "marketing_start_date": "20190304"}, {"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0574-0827-10)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "0574-0827-10", "marketing_start_date": "20140501"}], "brand_name": "Testosterone Cypionate", "product_id": "0574-0827_aa3130c8-5ef7-4fcc-8478-7c2dd9973fbe", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0574-0827", "dea_schedule": "CIII", "generic_name": "Testosterone Cypionate", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone Cypionate", "active_ingredients": [{"name": "TESTOSTERONE CYPIONATE", "strength": "200 mg/mL"}], "application_number": "ANDA091244", "marketing_category": "ANDA", "marketing_start_date": "20140501", "listing_expiration_date": "20261231"}