testosterone

Generic: testosterone

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler prasco laboratories
Dosage Form GEL
Routes
TRANSDERMAL
Active Ingredients

testosterone 12.5 mg/1.25g

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-953
Product ID 66993-953_c9fee58e-0843-4cf3-8d60-c578dc9a288f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021015
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2025-05-19

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 66993953
Hyphenated Format 66993-953

Supplemental Identifiers

RxCUI
1596780 1597123 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 NDA021015 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1.25g
source: ndc
Packaging
  • 2 BOTTLE, PUMP in 1 CARTON (66993-953-44) / 88 g in 1 BOTTLE, PUMP (66993-953-88)
source: ndc

Packages (1)

66993-953-44 2 BOTTLE, PUMP in 1 CARTON (66993-953-44) / 88 g in 1 BOTTLE, PUMP (66993-953-88)

Ingredients (1)

testosterone (12.5 mg/1.25g)

Linked Drug Pages (1)

Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "c9fee58e-0843-4cf3-8d60-c578dc9a288f", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1596780", "1597123", "1597129"], "spl_set_id": ["68b2375d-0365-4797-bc3d-63531c9f42fd"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PUMP in 1 CARTON (66993-953-44)  / 88 g in 1 BOTTLE, PUMP (66993-953-88)", "package_ndc": "66993-953-44", "marketing_start_date": "20250519"}], "brand_name": "Testosterone", "product_id": "66993-953_c9fee58e-0843-4cf3-8d60-c578dc9a288f", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "66993-953", "dea_schedule": "CIII", "generic_name": "testosterone", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "12.5 mg/1.25g"}], "application_number": "NDA021015", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250519", "listing_expiration_date": "20261231"}