testosterone

Generic: testosterone

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name testosterone
Generic Name testosterone
Labeler alembic pharmaceuticals inc.
Dosage Form GEL
Routes
TRANSDERMAL
Active Ingredients

testosterone 16.2 mg/g

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-552
Product ID 62332-552_62220e49-3381-41e3-a801-7f9a1e07c3b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213922
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2021-03-04

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 62332552
Hyphenated Format 62332-552

Supplemental Identifiers

RxCUI
1597076
UPC
0362332552887
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 ANDA213922 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 16.2 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (62332-552-88) / 88 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

62332-552-88 1 BOTTLE, PUMP in 1 CARTON (62332-552-88) / 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": ["TRANSDERMAL"], "spl_id": "62220e49-3381-41e3-a801-7f9a1e07c3b1", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0362332552887"], "unii": ["3XMK78S47O"], "rxcui": ["1597076"], "spl_set_id": ["21705fce-bc6c-41f6-aa92-fa6fc1c22fb6"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (62332-552-88)  / 88 g in 1 BOTTLE, PUMP", "package_ndc": "62332-552-88", "marketing_start_date": "20210304"}], "brand_name": "TESTOSTERONE", "product_id": "62332-552_62220e49-3381-41e3-a801-7f9a1e07c3b1", "dosage_form": "GEL", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "62332-552", "dea_schedule": "CIII", "generic_name": "TESTOSTERONE", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TESTOSTERONE", "active_ingredients": [{"name": "TESTOSTERONE", "strength": "16.2 mg/g"}], "application_number": "ANDA213922", "marketing_category": "ANDA", "marketing_start_date": "20210304", "listing_expiration_date": "20261231"}