FDA.reportPublic FDA data

BUSULFAN

Product NDC
0409-1112
11-digit product format
004091112
Labeler code
0409
Product ID
0409-1112_1e2080b5-8c77-4eb1-95bf-4cbd86c27995
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSULFAN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA205672
Marketing category
ANDA
Marketing start
2019-02-28
Substance
BUSULFAN
Active strength
6 mg/mL
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
BUSULFAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUSULFAN6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG1LN9045DK
Rxcui253113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5cd205af-1b5a-44f8-d007-fc9f5ee3cd5dProduct name920210518
0bcaeed6-5866-1c9f-3423-7db0fa4d0985Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1112-01BUSULFAN8 in 1 CARTONINJECTION, SOLUTION89
0409-1112-10BUSULFAN10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109
0409-1112-10BUSULFAN1 in 1 CARTONINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1112-01ML - Milliliter0409-11121f9fcf8c-2ecd-41d2-b136-dd6e43d136c112019-03-12
0409-1112-10ML - Milliliter0409-1112a2b72523-8375-4e75-87b4-5a986095b08212019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1112BUSULFAN INJECTION, SOLUTION [HOSPIRA, INC.]9Current NDC, Legacy NDC, 3 package rows20210811_b9c7f0dc-988d-466e-8031-400ec4f60f21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253113busulfan 60 MG in 10 ML InjectionPSNb9c7f0dc-988d-466e-8031-400ec4f60f219
25311310 ML busulfan 6 MG/ML InjectionSCDb9c7f0dc-988d-466e-8031-400ec4f60f219
253113busulfan 60 MG per 10 ML InjectionSYb9c7f0dc-988d-466e-8031-400ec4f60f219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1112-01004091112018 CARTON in 1 CARTON (0409-1112-01) / 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1112-10) / 10 mL in 1 VIAL, SINGLE-DOSE8 carton2019-02-280000-00-00NoNoCurrent
0409-1112-100040911121010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical