testosterone

Generic: testosterone

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler upsher-smith laboratories, llc
Dosage Form GEL
Routes
TRANSDERMAL
Active Ingredients

testosterone 16.2 mg/g

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-078
Product ID 24979-078_6bc0a687-0975-4eb9-8072-dbef18a45e54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209390
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-12-31

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 24979078
Hyphenated Format 24979-078

Supplemental Identifiers

RxCUI
1597076
UPC
0324979078151
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 ANDA209390 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 16.2 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (24979-078-15) / 88 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

24979-078-15 1 BOTTLE, PUMP in 1 CARTON (24979-078-15) / 88 g in 1 BOTTLE, PUMP

Ingredients (1)

testosterone (16.2 mg/g)

Linked Drug Pages (1)

Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "6bc0a687-0975-4eb9-8072-dbef18a45e54", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0324979078151"], "unii": ["3XMK78S47O"], "rxcui": ["1597076"], "spl_set_id": ["10dab294-6a43-4bb3-9d91-2d200c624ffb"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (24979-078-15)  / 88 g in 1 BOTTLE, PUMP", "package_ndc": "24979-078-15", "marketing_start_date": "20191231"}], "brand_name": "Testosterone", "product_id": "24979-078_6bc0a687-0975-4eb9-8072-dbef18a45e54", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "24979-078", "dea_schedule": "CIII", "generic_name": "Testosterone", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "16.2 mg/g"}], "application_number": "ANDA209390", "marketing_category": "ANDA", "marketing_start_date": "20191231", "listing_expiration_date": "20261231"}