FDA.reportPublic FDA data

TEPYLUTE

Product NDC
81927-106
11-digit product format
819270106
Labeler code
81927
Product ID
81927-106_ea45bb79-9b31-48f4-9785-a94c3be6c1e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiotepa
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Shorla Oncology Inc.
Application
NDA216984
Marketing category
NDA
Marketing start
2025-03-31
Substance
THIOTEPA
Active strength
10 mg/mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TEPYLUTE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THIOTEPA10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii905Z5W3GKH
Rxcui2700709, 2700712, 2709440, 2709442

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b9d03845-c04b-46cb-bb7e-9c6cffe3c163Product name420250618
d48e4a3f-d6a3-47a1-9357-dd5939f6049dProduct name120250227
d4b5276b-261e-446e-ba03-7cf7bbc1d8afProduct name320220718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81927-106-01TEPYLUTE10 mL in 1 VIAL, MULTI-DOSEINJECTION104
81927-106-01TEPYLUTE1 in 1 CARTONINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81927-106-01ML - Milliliter81927-106fbb8f7a5-7b26-4f6e-97aa-e1a641f1182412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81927-106TEPYLUTE (THIOTEPA) INJECTION [SHORLA ONCOLOGY INC.]3Current NDC, 2 package rows20250331_add44e98-a042-4e38-b870-beb36693805b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709442Tepylute 10 MG/ML Injectable SolutionPSNadd44e98-a042-4e38-b870-beb36693805b4
2700712Tepylute 15 MG in 1.5 ML InjectionPSNadd44e98-a042-4e38-b870-beb36693805b4
2709440thiotepa 10 MG/ML Injectable SolutionPSNadd44e98-a042-4e38-b870-beb36693805b4
2700709thiotepa 15 MG in 1.5 ML InjectionPSNadd44e98-a042-4e38-b870-beb36693805b4
27007121.5 ML thiotepa 10 MG/ML Injection [Tepylute]SBDadd44e98-a042-4e38-b870-beb36693805b4
2709442thiotepa 10 MG/ML Injectable Solution [Tepylute]SBDadd44e98-a042-4e38-b870-beb36693805b4
27007091.5 ML thiotepa 10 MG/ML InjectionSCDadd44e98-a042-4e38-b870-beb36693805b4
2709440thiotepa 10 MG/ML Injectable SolutionSCDadd44e98-a042-4e38-b870-beb36693805b4
27007091.5 ML TSPA 10 MG/ML InjectionSYadd44e98-a042-4e38-b870-beb36693805b4
27007121.5 ML TSPA 10 MG/ML Injection [Tepylute]SYadd44e98-a042-4e38-b870-beb36693805b4
2709442Tepylute 10 MG per 1 ML Injectable SolutionSYadd44e98-a042-4e38-b870-beb36693805b4
2700712Tepylute 10 MG/ML per 1.5 ML InjectionSYadd44e98-a042-4e38-b870-beb36693805b4
2700712Tepylute 15 MG per 1.5 ML InjectionSYadd44e98-a042-4e38-b870-beb36693805b4
2709440thiotepa 10 MG per 1 ML Injectable SolutionSYadd44e98-a042-4e38-b870-beb36693805b4
2700709thiotepa 10 MG/ML per 1.5 ML InjectionSYadd44e98-a042-4e38-b870-beb36693805b4
2700709thiotepa 15 MG per 1.5 ML InjectionSYadd44e98-a042-4e38-b870-beb36693805b4
2709440TSPA 10 MG/ML Injectable SolutionSYadd44e98-a042-4e38-b870-beb36693805b4
2709442TSPA 10 MG/ML Injectable Solution [Tepylute]SYadd44e98-a042-4e38-b870-beb36693805b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81927-106-01819270106011 VIAL, MULTI-DOSE in 1 CARTON (81927-106-01) / 10 mL in 1 VIAL, MULTI-DOSE2025-03-31NoNoHistorical