testosterone

Generic: testosterone

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

testosterone 12.5 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1121
Product ID 0832-1121_39853cd7-bfd1-848f-e063-6294a90a49e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA204399
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2014-06-16

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 08321121
Hyphenated Format 0832-1121

Supplemental Identifiers

RxCUI
1596780 1597129
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 NDA204399 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 2 BOTTLE, PUMP in 1 CARTON (0832-1121-42) / 60 GEL, METERED in 1 BOTTLE, PUMP (0832-1121-40)
source: ndc

Packages (1)

0832-1121-42 2 BOTTLE, PUMP in 1 CARTON (0832-1121-42) / 60 GEL, METERED in 1 BOTTLE, PUMP (0832-1121-40)

Ingredients (1)

testosterone (12.5 mg/1)

Linked Drug Pages (1)

Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "39853cd7-bfd1-848f-e063-6294a90a49e4", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1596780", "1597129"], "spl_set_id": ["a887020f-b41f-49fe-8379-f01147b2a796"], "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": "2 BOTTLE, PUMP in 1 CARTON (0832-1121-42)  / 60 GEL, METERED in 1 BOTTLE, PUMP (0832-1121-40)", "package_ndc": "0832-1121-42", "marketing_start_date": "20140616"}], "brand_name": "Testosterone", "product_id": "0832-1121_39853cd7-bfd1-848f-e063-6294a90a49e4", "dosage_form": "GEL, METERED", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0832-1121", "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": "12.5 mg/1"}], "application_number": "NDA204399", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20140616", "listing_expiration_date": "20261231"}