CYCLOPHOSPHAMIDE

Product NDC
54879-021
11-digit product format
548790021
Labeler code
54879
Product ID
54879-021_ee2521c8-3bcc-1b0e-e053-2995a90a5578
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOPHOSPHAMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
STI Pharma LLC
Application
ANDA209872
Marketing category
ANDA
Marketing start
2018-05-08
Marketing end
0000-00-00
Substance
CYCLOPHOSPHAMIDE
Active strength
25 mg/1
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
54879-021-012026-01-29C16284748780-149896155-c221-586f-e063-e6dba90add904ebe66e7-5e0d-41ff-8ef9-e4c30a65f213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54879-021-01EA - Each54879-0214fdbd13a-95b4-40d5-96d1-92e1cc191c2112018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54879-021CYCLOPHOSPHAMIDE CAPSULE [STI PHARMA LLC]6Legacy NDC20240113_4ebe66e7-5e0d-41ff-8ef9-e4c30a65f213.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54879-021-0154879002101100 CAPSULE in 1 BOTTLE (54879-021-01) 100 capsule2018-05-080000-00-00NoNoCurrent