testosterone

Generic: testosterone

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler actavis pharma, inc.
Dosage Form GEL
Routes
TRANSDERMAL
Active Ingredients

testosterone 50 mg/5g

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3524
Product ID 0591-3524_2e95e259-83f9-4189-885b-0d119c3a3885
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091073
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2017-10-12

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 05913524
Hyphenated Format 0591-3524

Supplemental Identifiers

RxCUI
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 ANDA091073 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5g
source: ndc
Packaging
  • 30 TUBE in 1 CARTON (0591-3524-30) / 5 g in 1 TUBE (0591-3524-26)
source: ndc

Packages (1)

0591-3524-30 30 TUBE in 1 CARTON (0591-3524-30) / 5 g in 1 TUBE (0591-3524-26)

Ingredients (1)

testosterone (50 mg/5g)

Linked Drug Pages (1)

Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "2e95e259-83f9-4189-885b-0d119c3a3885", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1597129"], "spl_set_id": ["e18b4495-c5a3-4a7f-9636-179320784381"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TUBE in 1 CARTON (0591-3524-30)  / 5 g in 1 TUBE (0591-3524-26)", "package_ndc": "0591-3524-30", "marketing_start_date": "20171012"}], "brand_name": "Testosterone", "product_id": "0591-3524_2e95e259-83f9-4189-885b-0d119c3a3885", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0591-3524", "dea_schedule": "CIII", "generic_name": "Testosterone", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "50 mg/5g"}], "application_number": "ANDA091073", "marketing_category": "ANDA", "marketing_start_date": "20171012", "listing_expiration_date": "20271231"}