Thiotepa

Product NDC
69539-123
11-digit product format
695390123
Labeler code
69539
Product ID
69539-123_1c6a2caa-abd7-4e8b-830f-e4fcf73e949a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Thiotepa
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA213049
Marketing category
ANDA
Marketing start
2020-03-04
Marketing end
0000-00-00
Substance
THIOTEPA
Active strength
15 mg/1
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69539-123-012025-11-26C16284748780-12cef2736-959d-d83d-e063-dadaa90ab31f6cb2e63c-1180-4201-b596-233d1b1a5dc8
69539-123-012025-01-30C16284748780-12cef2736-959d-d83d-e063-dadaa90ab31f6cb2e63c-1180-4201-b596-233d1b1a5dc8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-123THIOTEPA INJECTION, POWDER, FOR SOLUTION [MSN LABORATORIES PRIVATE LIMITED]3Legacy NDC20200309_6cb2e63c-1180-4201-b596-233d1b1a5dc8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69539-123-01695390123011 VIAL, GLASS in 1 BOX (69539-123-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS2020-03-040000-00-00NoNoCurrent