testosterone cypionate

Generic: testosterone cypionate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone cypionate
Generic Name testosterone cypionate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

testosterone cypionate 200 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9005
Product ID 0143-9005_e9157af8-c85f-4d56-82f7-4f5d51d04ac3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091244
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2021-11-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439005
Hyphenated Format 0143-9005

Supplemental Identifiers

RxCUI
835840
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 in 1 CARTON (0143-9005-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

0143-9005-01 1 VIAL in 1 CARTON (0143-9005-01) / 10 mL in 1 VIAL

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": "e9157af8-c85f-4d56-82f7-4f5d51d04ac3", "openfda": {"unii": ["M0XW1UBI14"], "rxcui": ["835840"], "spl_set_id": ["5ca67491-4b30-4a47-af0a-be250215d1f0"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0143-9005-01)  / 10 mL in 1 VIAL", "package_ndc": "0143-9005-01", "marketing_start_date": "20211122"}], "brand_name": "Testosterone Cypionate", "product_id": "0143-9005_e9157af8-c85f-4d56-82f7-4f5d51d04ac3", "dosage_form": "INJECTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0143-9005", "dea_schedule": "CIII", "generic_name": "Testosterone Cypionate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "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": "20211122", "listing_expiration_date": "20261231"}