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 SOLUTION
Routes
TOPICAL
Active Ingredients

testosterone 30 mg/1.5mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-610
Product ID 45802-610_49fac6b0-d016-4de8-a375-64de3e07aaa0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204255
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2017-06-28

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 45802610
Hyphenated Format 45802-610

Supplemental Identifiers

RxCUI
1599949
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 ANDA204255 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1.5mL
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (45802-610-01) / 110 mL in 1 BOTTLE, PUMP
source: ndc

Packages (1)

45802-610-01 1 BOTTLE, PUMP in 1 CARTON (45802-610-01) / 110 mL in 1 BOTTLE, PUMP

Ingredients (1)

testosterone (30 mg/1.5mL)

Linked Drug Pages (1)

testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "49fac6b0-d016-4de8-a375-64de3e07aaa0", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1599949"], "spl_set_id": ["c0c56607-e995-4bed-9c62-e33a722b38b5"], "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": "1 BOTTLE, PUMP in 1 CARTON (45802-610-01)  / 110 mL in 1 BOTTLE, PUMP", "package_ndc": "45802-610-01", "marketing_start_date": "20170628"}], "brand_name": "testosterone", "product_id": "45802-610_49fac6b0-d016-4de8-a375-64de3e07aaa0", "dosage_form": "SOLUTION", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "45802-610", "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": "30 mg/1.5mL"}], "application_number": "ANDA204255", "marketing_category": "ANDA", "marketing_start_date": "20170628", "listing_expiration_date": "20261231"}