testosterone gel, 1% (21922-019)

Drug Facts

Product Profile

Brand Name testosterone gel, 1%

Generic Name testosterone gel, 1%

Labeler encube ethicals, inc.

Dosage Form GEL

Routes

TRANSDERMAL

Active Ingredients

testosterone 10 mg/g

Manufacturer

Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-019

Product ID 21922-019_afa51eef-714f-4b19-8c35-debee6cb00c4

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212984

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2021-01-10

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 21922019

Hyphenated Format 21922-019

Supplemental Identifiers

RxCUI

1596780 1597123 1597129

UPC

0321922019025

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 gel, 1% (source: ndc)

Generic Name testosterone gel, 1% (source: ndc)

Application Number ANDA212984 (source: ndc)

Routes

TRANSDERMAL

source: ndc

Resolved Composition

Strengths

10 mg/g

source: ndc

Packaging

30 PACKET in 1 CARTON (21922-019-02) / 5 g in 1 PACKET
2 CONTAINER in 1 CARTON (21922-019-47) / 75 g in 1 CONTAINER
30 PACKET in 1 CARTON (21922-019-52) / 25 g in 1 PACKET

source: ndc

Packages (3)

21922-019-02 30 PACKET in 1 CARTON (21922-019-02) / 5 g in 1 PACKET 21922-019-47 2 CONTAINER in 1 CARTON (21922-019-47) / 75 g in 1 CONTAINER 21922-019-52 30 PACKET in 1 CARTON (21922-019-52) / 25 g in 1 PACKET

Ingredients (1)

testosterone (10 mg/g)

Linked Drug Pages (1)

Testosterone Gel, 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TRANSDERMAL"], "spl_id": "afa51eef-714f-4b19-8c35-debee6cb00c4", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0321922019025"], "unii": ["3XMK78S47O"], "rxcui": ["1596780", "1597123", "1597129"], "spl_set_id": ["7d655d6d-01da-488c-bd4e-c7fbe0ace38c"], "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": "30 PACKET in 1 CARTON (21922-019-02)  / 5 g in 1 PACKET", "package_ndc": "21922-019-02", "marketing_start_date": "20210110"}, {"sample": false, "description": "2 CONTAINER in 1 CARTON (21922-019-47)  / 75 g in 1 CONTAINER", "package_ndc": "21922-019-47", "marketing_start_date": "20240214"}, {"sample": false, "description": "30 PACKET in 1 CARTON (21922-019-52)  / 25 g in 1 PACKET", "package_ndc": "21922-019-52", "marketing_start_date": "20240812"}], "brand_name": "Testosterone Gel, 1%", "product_id": "21922-019_afa51eef-714f-4b19-8c35-debee6cb00c4", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "21922-019", "dea_schedule": "CIII", "generic_name": "Testosterone Gel, 1%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone Gel, 1%", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "10 mg/g"}], "application_number": "ANDA212984", "marketing_category": "ANDA", "marketing_start_date": "20210110", "listing_expiration_date": "20261231"}