FDA.reportPublic FDA data

Busulfan

Product NDC
70121-1244
11-digit product format
701211244
Labeler code
70121
Product ID
70121-1244_973e7d91-192a-4dea-9056-4f98c37cdc6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Busulfan
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA209580
Marketing category
ANDA
Marketing start
2017-12-18
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
70121-1244-1Busulfan10 mL in 1 VIAL, SINGLE-DOSEINJECTION107
70121-1244-7Busulfan8 in 1 CARTONINJECTION87

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1244-1ML - Milliliter70121-1244ab855146-b7ff-45e7-a635-2cf79260c33f12018-02-20
70121-1244-7ML - Milliliter70121-124434f5e047-cec3-4e08-a58d-47e21bd08af912018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1244BUSULFAN INJECTION [AMNEAL PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 2 package rows20231228_ac9448da-37ad-4609-9aef-eedf8be0f69c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253113busulfan 60 MG in 10 ML InjectionPSNac9448da-37ad-4609-9aef-eedf8be0f69c7
25311310 ML busulfan 6 MG/ML InjectionSCDac9448da-37ad-4609-9aef-eedf8be0f69c7
253113busulfan 60 MG per 10 ML InjectionSYac9448da-37ad-4609-9aef-eedf8be0f69c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1244-17012112440110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
70121-1244-7701211244078 VIAL, SINGLE-DOSE in 1 CARTON (70121-1244-7) / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1244-1) 2017-12-180000-00-00NoNoCurrent