Tlando

Generic: testosterone undecanoate

Labeler: Antares Pharma, Inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive

Drug Facts

Product Profile

Brand Name Tlando
Generic Name testosterone undecanoate
Labeler Antares Pharma, Inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

TESTOSTERONE UNDECANOATE 112.5 mg/1

Identifiers & Regulatory

Product NDC 54436-112
Product ID 54436-112_2d07e538-9230-6093-e063-6394a90a9d8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208088
DEA Schedule CIII
Marketing Start 2022-04-15
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54436112
Hyphenated Format 54436-112

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 Tlando (source: ndc)
Generic Name testosterone undecanoate (source: ndc)
Application Number NDA208088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 112.5 mg/1
source: ndc
Packaging
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (54436-112-20)
source: ndc

Packages (1)

54436-112-20 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (54436-112-20)

Ingredients (1)

TESTOSTERONE UNDECANOATE (112.5 mg/1)

Linked Drug Pages (1)

Tlando ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d07e538-9230-6093-e063-6394a90a9d8f", "openfda": {"upc": ["0354436112203"], "unii": ["H16A5VCT9C"], "rxcui": ["2599054", "2599060"], "spl_set_id": ["479b55bd-2023-486a-8922-3b1de48b935c"], "manufacturer_name": ["Antares Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (54436-112-20)", "package_ndc": "54436-112-20", "marketing_end_date": "20260228", "marketing_start_date": "20220415"}], "brand_name": "Tlando", "product_id": "54436-112_2d07e538-9230-6093-e063-6394a90a9d8f", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "54436-112", "dea_schedule": "CIII", "generic_name": "testosterone undecanoate", "labeler_name": "Antares Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tlando", "active_ingredients": [{"name": "TESTOSTERONE UNDECANOATE", "strength": "112.5 mg/1"}], "application_number": "NDA208088", "marketing_category": "NDA", "marketing_end_date": "20260228", "marketing_start_date": "20220415"}