androgel

Generic: testosterone

Labeler: ascend therapeutics u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name androgel
Generic Name testosterone
Labeler ascend therapeutics u.s., llc
Dosage Form GEL
Routes
TRANSDERMAL
Active Ingredients

testosterone 10 mg/g

Manufacturer
ASCEND Therapeutics U.S., LLC

Identifiers & Regulatory

Product NDC 17139-501
Product ID 17139-501_14a12387-5802-4ec9-8a75-85faebddd18c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021015
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-02-17

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 17139501
Hyphenated Format 17139-501

Supplemental Identifiers

RxCUI
1596780 1597074 1597123 1597124 1597129 1597130
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 androgel (source: ndc)
Generic Name testosterone (source: ndc)
Application Number NDA021015 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 2 BOTTLE, PUMP in 1 CARTON (17139-501-02) / 75 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

17139-501-02 2 BOTTLE, PUMP in 1 CARTON (17139-501-02) / 75 g in 1 BOTTLE, PUMP

Ingredients (1)

testosterone (10 mg/g)

Linked Drug Pages (1)

AndroGel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "14a12387-5802-4ec9-8a75-85faebddd18c", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1596780", "1597074", "1597123", "1597124", "1597129", "1597130"], "spl_set_id": ["f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["ASCEND Therapeutics U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PUMP in 1 CARTON (17139-501-02)  / 75 g in 1 BOTTLE, PUMP", "package_ndc": "17139-501-02", "marketing_start_date": "20230217"}], "brand_name": "AndroGel", "product_id": "17139-501_14a12387-5802-4ec9-8a75-85faebddd18c", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "17139-501", "dea_schedule": "CIII", "generic_name": "Testosterone", "labeler_name": "ASCEND Therapeutics U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AndroGel", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "10 mg/g"}], "application_number": "NDA021015", "marketing_category": "NDA", "marketing_start_date": "20230217", "listing_expiration_date": "20261231"}