FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72960-11272960-112-05DDiscontinued by firm2026-08-07
excluded packagepackage72960-11272960-112-06DDiscontinued by firm2026-08-07

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E211KPY694Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2612454Internal RxNorm lookup
2612456Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f74Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAXXIFYBOTULINUM TOXIN TYPE ARevance Therapeutics, Inc.3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f742026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761127
ndc (product): 72960-112

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761127DaxxifydaxibotulinumtoxinA-lanm351(a)Rx2026-06-01

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