Busulfan

Product NDC
72606-559
11-digit product format
726060559
Labeler code
72606
Product ID
72606-559_63ede55c-8326-4a52-a873-f46ce8427ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Busulfan
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
CELLTRION USA, INC.
Application
ANDA210931
Marketing category
ANDA
Marketing start
2019-12-01
Marketing end
0000-00-00
Substance
BUSULFAN
Active strength
6 mg/mL
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72606-559-022025-03-13C16284748780-12cef2736-a30a-d83d-e063-dadaa90ab31f3ab9b45c-b63a-4152-a242-4f218c520b3b
72606-559-022025-01-30C16284748780-12cef2736-a30a-d83d-e063-dadaa90ab31f3ab9b45c-b63a-4152-a242-4f218c520b3b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-559-01ML - Milliliter72606-5592039e603-46f3-4f4c-98a1-b36c54bb206b12020-03-10
72606-559-02ML - Milliliter72606-55970235edd-62bd-4f80-9a7e-633a9b231dfc12020-03-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72606-559-02726060559028 CARTON in 1 CARTON (72606-559-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON (72606-559-01) > 10 mL in 1 VIAL, SINGLE-DOSE8 carton2019-12-010000-00-00NoNoCurrent