testosterone enanthate

Generic: testosterone enanthate

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

Drug Facts

Product Profile

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

testosterone enanthate 200 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9750
Product ID 0143-9750_d56a5e5d-c88f-4f0d-84b4-1be06ca6ebba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091120
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2012-09-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439750
Hyphenated Format 0143-9750

Supplemental Identifiers

RxCUI
835809
UNII
7Z6522T8N9

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 enanthate (source: ndc)
Generic Name testosterone enanthate (source: ndc)
Application Number ANDA091120 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01)
source: ndc

Packages (1)

0143-9750-01 5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01)

Ingredients (1)

testosterone enanthate (200 mg/mL)

Linked Drug Pages (1)

TESTOSTERONE ENANTHATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "d56a5e5d-c88f-4f0d-84b4-1be06ca6ebba", "openfda": {"unii": ["7Z6522T8N9"], "rxcui": ["835809"], "spl_set_id": ["e89d6458-428c-4256-97a3-f1fa851293c1"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, MULTI-DOSE (0143-9750-01)", "package_ndc": "0143-9750-01", "marketing_start_date": "20120918"}], "brand_name": "TESTOSTERONE ENANTHATE", "product_id": "0143-9750_d56a5e5d-c88f-4f0d-84b4-1be06ca6ebba", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0143-9750", "dea_schedule": "CIII", "generic_name": "TESTOSTERONE ENANTHATE", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TESTOSTERONE ENANTHATE", "active_ingredients": [{"name": "TESTOSTERONE ENANTHATE", "strength": "200 mg/mL"}], "application_number": "ANDA091120", "marketing_category": "ANDA", "marketing_start_date": "20120918", "listing_expiration_date": "20261231"}