natesto nasal gel

Generic: testosterone

Labeler: acerus pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name natesto nasal gel
Generic Name testosterone
Labeler acerus pharmaceuticals corporation
Dosage Form GEL, METERED
Routes
NASAL
Active Ingredients

testosterone 5.5 mg/.122g

Manufacturer
Acerus Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 42667-5511
Product ID 42667-5511_3ab4a3a7-6d2d-ac70-e063-6394a90afb84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205488
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2020-05-08

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 426675511
Hyphenated Format 42667-5511

Supplemental Identifiers

RxCUI
1596782 1596784
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 natesto nasal gel (source: ndc)
Generic Name testosterone (source: ndc)
Application Number NDA205488 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 5.5 mg/.122g
source: ndc
Packaging
  • 1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR
source: ndc

Packages (1)

42667-5511-1 1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR

Ingredients (1)

testosterone (5.5 mg/.122g)

Linked Drug Pages (1)

Natesto nasal gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "3ab4a3a7-6d2d-ac70-e063-6394a90afb84", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1596782", "1596784"], "spl_set_id": ["dea6bed1-eaca-11e3-ac10-0800200c9a66"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Acerus Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 BOX (42667-5511-1)  / 11 g in 1 APPLICATOR", "package_ndc": "42667-5511-1", "marketing_start_date": "20200508"}], "brand_name": "Natesto nasal gel", "product_id": "42667-5511_3ab4a3a7-6d2d-ac70-e063-6394a90afb84", "dosage_form": "GEL, METERED", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "42667-5511", "dea_schedule": "CIII", "generic_name": "testosterone", "labeler_name": "Acerus Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Natesto", "brand_name_suffix": "nasal gel", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "5.5 mg/.122g"}], "application_number": "NDA205488", "marketing_category": "NDA", "marketing_start_date": "20200508", "listing_expiration_date": "20261231"}