testosterone

Generic: testosterone

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler padagis israel pharmaceuticals ltd
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

testosterone 40.5 mg/2.5g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-366
Product ID 45802-366_a7c10e20-f92f-4b14-a281-8118abfd4809
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205781
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-06-06

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 45802366
Hyphenated Format 45802-366

Supplemental Identifiers

RxCUI
1597076 1597120 1597126
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 testosterone (source: ndc)
Generic Name testosterone (source: ndc)
Application Number ANDA205781 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40.5 mg/2.5g
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (45802-366-65) / 2.5 g in 1 PACKET (45802-366-02)
source: ndc

Packages (1)

45802-366-65 30 PACKET in 1 CARTON (45802-366-65) / 2.5 g in 1 PACKET (45802-366-02)

Ingredients (1)

testosterone (40.5 mg/2.5g)

Linked Drug Pages (1)

testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a7c10e20-f92f-4b14-a281-8118abfd4809", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1597076", "1597120", "1597126"], "spl_set_id": ["54fcdcb9-fb0e-4164-9e51-f2a5feae3217"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (45802-366-65)  / 2.5 g in 1 PACKET (45802-366-02)", "package_ndc": "45802-366-65", "marketing_start_date": "20190606"}], "brand_name": "testosterone", "product_id": "45802-366_a7c10e20-f92f-4b14-a281-8118abfd4809", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "45802-366", "dea_schedule": "CIII", "generic_name": "testosterone", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "40.5 mg/2.5g"}], "application_number": "ANDA205781", "marketing_category": "ANDA", "marketing_start_date": "20190606", "listing_expiration_date": "20261231"}