Thiotepa

Product NDC
70860-220
11-digit product format
708600220
Labeler code
70860
Product ID
70860-220_6a12eeea-ab98-42fe-8c5b-817d884dd44b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thiotepa
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA211831
Marketing category
ANDA
Marketing start
2022-10-15
Marketing end
0000-00-00
Substance
THIOTEPA
Active strength
15 mg/1.5mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-220-022025-02-03C16284748780-11030e364-fc4d-111a-e063-dadaa90a10e269b6261a-f39d-475e-9613-1607dbbc956f
70860-220-022024-01-30C16284748780-11030e364-fc4d-111a-e063-dadaa90a10e269b6261a-f39d-475e-9613-1607dbbc956f

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70860-220-02708600220021 VIAL, SINGLE-DOSE in 1 CARTON (70860-220-02) > 1.5 mL in 1 VIAL, SINGLE-DOSE2022-10-150000-00-00NoNoCurrent