FDA.reportPublic FDA data

Thiotepa

Product NDC
71288-157
11-digit product format
712880157
Labeler code
71288
Product ID
71288-157_d75a277e-a2ff-4409-8ef3-34b7fd2198f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Thiotepa
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler
Meitheal Pharmaceuticals Inc
Application
ANDA216037
Marketing category
ANDA
Marketing start
2023-12-26
Substance
THIOTEPA
Active strength
100 mg/1
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
Thiotepa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THIOTEPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii905Z5W3GKH
Rxcui1660004, 1660009

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
71288-157-10Thiotepa1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION14
71288-157-10Thiotepa1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-157-10EA - Each71288-1572354480f-9dd6-4123-977c-13b0f33b8e1912024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-157THIOTEPA INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC]4Current NDC, 2 package rows20231229_4b4725eb-95f1-45cc-852f-152beb5f1e2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1660004thiotepa 100 MG InjectionPSN4b4725eb-95f1-45cc-852f-152beb5f1e2c4
1660009thiotepa 15 MG InjectionPSN4b4725eb-95f1-45cc-852f-152beb5f1e2c4
1660004thiotepa 100 MG InjectionSCD4b4725eb-95f1-45cc-852f-152beb5f1e2c4
1660009thiotepa 15 MG InjectionSCD4b4725eb-95f1-45cc-852f-152beb5f1e2c4
1660004TSPA 100 MG InjectionSY4b4725eb-95f1-45cc-852f-152beb5f1e2c4
1660009TSPA 15 MG InjectionSY4b4725eb-95f1-45cc-852f-152beb5f1e2c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-157-10712880157101 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2023-12-26NoNoHistorical