testosterone

Generic: testosterone

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TRANSDERMAL
Active Ingredients

testosterone 16.2 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-030
Product ID 21922-030_006ee4e6-e4d9-49d1-b481-1667c03378af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208620
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-06-05

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 21922030
Hyphenated Format 21922-030

Supplemental Identifiers

RxCUI
1597076
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 ANDA208620 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 16.2 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (21922-030-20) / 88 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

21922-030-20 1 BOTTLE, PUMP in 1 CARTON (21922-030-20) / 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": "006ee4e6-e4d9-49d1-b481-1667c03378af", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1597076"], "spl_set_id": ["44a04f66-fd2a-45c7-934e-8f14c023ce14"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (21922-030-20)  / 88 g in 1 BOTTLE, PUMP", "package_ndc": "21922-030-20", "marketing_start_date": "20240605"}], "brand_name": "TESTOSTERONE", "product_id": "21922-030_006ee4e6-e4d9-49d1-b481-1667c03378af", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "21922-030", "dea_schedule": "CIII", "generic_name": "testosterone", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TESTOSTERONE", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "16.2 mg/g"}], "application_number": "ANDA208620", "marketing_category": "ANDA", "marketing_start_date": "20240605", "listing_expiration_date": "20261231"}