testopel

Generic: testosterone

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

Drug Facts

Product Profile

Brand Name testopel
Generic Name testosterone
Labeler endo usa, inc.
Dosage Form PELLET
Routes
SUBCUTANEOUS
Active Ingredients

testosterone 75 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 66887-004
Product ID 66887-004_0a13cf12-e51e-4d3d-a7c4-ea74712e6db2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080911
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2014-10-31

Pharmacologic Class

Established (EPC)
androgen [epc]
Mechanism of Action
androgen receptor agonists [moa]
Chemical Structure
androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66887004
Hyphenated Format 66887-004

Supplemental Identifiers

RxCUI
318240 404405
UNII
3XMK78S47O
NUI
N0000175824 N0000000146 M0001109

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 testopel (source: ndc)
Generic Name testosterone (source: ndc)
Application Number ANDA080911 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 10 AMPULE in 1 BOX (66887-004-10) / 1 PELLET in 1 AMPULE (66887-004-01)
  • 100 AMPULE in 1 BOX (66887-004-20) / 1 PELLET in 1 AMPULE (66887-004-01)
source: ndc

Packages (2)

66887-004-10 10 AMPULE in 1 BOX (66887-004-10) / 1 PELLET in 1 AMPULE (66887-004-01) 66887-004-20 100 AMPULE in 1 BOX (66887-004-20) / 1 PELLET in 1 AMPULE (66887-004-01)

Ingredients (1)

testosterone (75 mg/1)

Linked Drug Pages (1)

Testopel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "0a13cf12-e51e-4d3d-a7c4-ea74712e6db2", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["318240", "404405"], "spl_set_id": ["03b9c0b1-5884-11e4-8ed6-0800200c9a66"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 BOX (66887-004-10)  / 1 PELLET in 1 AMPULE (66887-004-01)", "package_ndc": "66887-004-10", "marketing_start_date": "20141031"}, {"sample": false, "description": "100 AMPULE in 1 BOX (66887-004-20)  / 1 PELLET in 1 AMPULE (66887-004-01)", "package_ndc": "66887-004-20", "marketing_start_date": "20141031"}], "brand_name": "Testopel", "product_id": "66887-004_0a13cf12-e51e-4d3d-a7c4-ea74712e6db2", "dosage_form": "PELLET", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "66887-004", "dea_schedule": "CIII", "generic_name": "testosterone", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testopel", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "75 mg/1"}], "application_number": "ANDA080911", "marketing_category": "ANDA", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}