testosterone

Generic: testosterone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler bryant ranch prepack
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

testosterone 16.2 mg/g

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8455
Product ID 63629-8455_7829d759-de46-4f02-b3d5-13ca4b4c86e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204268
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2018-10-12

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 636298455
Hyphenated Format 63629-8455

Supplemental Identifiers

RxCUI
1597076
UNII
3XMK78S47O
NUI
N0000175824 N0000000146 M0001109

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 ANDA204268 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 16.2 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (63629-8455-1) / 88 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

63629-8455-1 1 BOTTLE, PUMP in 1 CARTON (63629-8455-1) / 88 g in 1 BOTTLE, PUMP

Ingredients (1)

testosterone (16.2 mg/g)

Linked Drug Pages (1)

testosterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7829d759-de46-4f02-b3d5-13ca4b4c86e4", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["3XMK78S47O"], "rxcui": ["1597076"], "spl_set_id": ["78384754-5883-46b1-84e7-c063b4b4be82"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (63629-8455-1)  / 88 g in 1 BOTTLE, PUMP", "package_ndc": "63629-8455-1", "marketing_start_date": "20181012"}], "brand_name": "testosterone", "product_id": "63629-8455_7829d759-de46-4f02-b3d5-13ca4b4c86e4", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "63629-8455", "dea_schedule": "CIII", "generic_name": "testosterone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "testosterone", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "16.2 mg/g"}], "application_number": "ANDA204268", "marketing_category": "ANDA", "marketing_start_date": "20181012", "listing_expiration_date": "20261231"}