DAXXIFY

Product NDC
72960-112
11-digit product format
729600112
Labeler code
72960
Product ID
72960-112_71c76e28-0eb6-487e-a53b-4c9e78021e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
botulinum toxin type A
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Revance Therapeutics, Inc.
Application
BLA761127
Marketing category
BLA
Marketing start
2022-09-20
Substance
BOTULINUM TOXIN TYPE A
Active strength
100 U/1.2mL
Pharmacologic classes
Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DAXXIFY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOTULINUM TOXIN TYPE A100 U/1.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE211KPY694
Rxcui2612454, 2612456

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2a92e090-adb9-48d2-ae5f-5956e4b6ad90Product name120231024
525448fb-6d30-4c07-bb80-9a8499bd8113Product name120230627
0cf2215a-e8b6-4688-9989-d0fcd154e4b8Product name120170725
8c498f95-3b71-4acf-9882-f567b5cc4a2aProduct name120160208
e9681bd0-ddf1-421f-88c4-4337e89d5421Product name120160208
a42a1284-ee26-4b9f-a2b3-1ba05f250710Product name120151202
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72960-112-01DAXXIFY1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112
72960-112-01DAXXIFY1.2 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1.212
72960-112-02DAXXIFY1.2 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1.212
72960-112-02DAXXIFY1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112
72960-112-05DAXXIFY1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112
72960-112-05DAXXIFY1.2 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1.212
72960-112-06DAXXIFY1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112
72960-112-06DAXXIFY1.2 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1.212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72960-112-01EA - Each72960-1121677f609-51cb-4b14-a523-c07c2e92764112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72960-112DAXXIFY (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVANCE THERAPEUTICS, INC.]10Current NDC, Legacy NDC, 8 package rows20240202_3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2612454daxibotulinumtoxinA-lanm 100 UNT InjectionPSN3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f7412
2612456Daxxify 100 UNT InjectionPSN3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f7412
2612456daxibotulinumtoxinA-lanm 100 UNT Injection [Daxxify]SBD3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f7412
2612454daxibotulinumtoxinA-lanm 100 UNT InjectionSCD3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f7412
2612456Daxxify 100 UNT InjectionSY3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f7412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72960-112-01729600112011 VIAL, SINGLE-USE in 1 CARTON (72960-112-01) / 1.2 mL in 1 VIAL, SINGLE-USE2022-09-200000-00-00NoNoCurrent
72960-112-02729600112021 VIAL, SINGLE-USE in 1 CARTON (72960-112-02) / 1.2 mL in 1 VIAL, SINGLE-USE2022-09-20YesNoCurrent
72960-112-05729600112051 in 1 CARTONHistorical
72960-112-06729600112061 in 1 CARTONHistorical