tepylute

Generic: thiotepa

Labeler: shorla oncology inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tepylute
Generic Name thiotepa
Labeler shorla oncology inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

thiotepa 10 mg/mL

Manufacturer
Shorla Oncology Inc.

Identifiers & Regulatory

Product NDC 81927-106
Product ID 81927-106_ea45bb79-9b31-48f4-9785-a94c3be6c1e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216984
Listing Expiration 2026-12-31
Marketing Start 2025-03-31

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81927106
Hyphenated Format 81927-106

Supplemental Identifiers

RxCUI
2700709 2700712 2709440 2709442
UNII
905Z5W3GKH
NUI
N0000000236 N0000175558

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 tepylute (source: ndc)
Generic Name thiotepa (source: ndc)
Application Number NDA216984 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

81927-106-01 1 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

thiotepa (10 mg/mL)

Linked Drug Pages (1)

TEPYLUTE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ea45bb79-9b31-48f4-9785-a94c3be6c1e9", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["905Z5W3GKH"], "rxcui": ["2700709", "2700712", "2709440", "2709442"], "spl_set_id": ["add44e98-a042-4e38-b870-beb36693805b"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Shorla Oncology Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "81927-106-01", "marketing_start_date": "20250331"}], "brand_name": "TEPYLUTE", "product_id": "81927-106_ea45bb79-9b31-48f4-9785-a94c3be6c1e9", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "81927-106", "generic_name": "thiotepa", "labeler_name": "Shorla Oncology Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEPYLUTE", "active_ingredients": [{"name": "THIOTEPA", "strength": "10 mg/mL"}], "application_number": "NDA216984", "marketing_category": "NDA", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}