testosterone

Generic: testosterone

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler amneal pharmaceuticals ny llc
Dosage Form GEL, METERED
Routes
TOPICAL
Active Ingredients

testosterone 20.25 mg/1.25g

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1013
Product ID 69238-1013_3fad47af-e17f-4a02-9520-54e80cfc54e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207373
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-04-10

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 692381013
Hyphenated Format 69238-1013

Supplemental Identifiers

RxCUI
1597076
UPC
0369238101324
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 ANDA207373 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20.25 mg/1.25g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (69238-1013-2) / 88 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

69238-1013-2 1 BOTTLE, PUMP in 1 CARTON (69238-1013-2) / 88 g in 1 BOTTLE, PUMP

Ingredients (1)

testosterone (20.25 mg/1.25g)

Linked Drug Pages (1)

Testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3fad47af-e17f-4a02-9520-54e80cfc54e4", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0369238101324"], "unii": ["3XMK78S47O"], "rxcui": ["1597076"], "spl_set_id": ["f9888b14-67f4-4c87-8f7b-d51baef9891b"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (69238-1013-2)  / 88 g in 1 BOTTLE, PUMP", "package_ndc": "69238-1013-2", "marketing_start_date": "20190410"}], "brand_name": "Testosterone", "product_id": "69238-1013_3fad47af-e17f-4a02-9520-54e80cfc54e4", "dosage_form": "GEL, METERED", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "69238-1013", "dea_schedule": "CIII", "generic_name": "Testosterone", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "20.25 mg/1.25g"}], "application_number": "ANDA207373", "marketing_category": "ANDA", "marketing_start_date": "20190410", "listing_expiration_date": "20261231"}