FDA.reportPublic FDA data

Jeuveau

Product NDC
72301-595
11-digit product format
723010595
Labeler code
72301
Product ID
72301-595_7f7323c9-a2c0-49f8-915f-439fd59cfe5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prabotulinum Toxin Type A
Dosage form
POWDER
Route
INTRAMUSCULAR
Labeler
Evolus, Inc.
Application
BLA761085
Marketing category
BLA
Marketing start
2019-02-13
Substance
BOTULINUM TOXIN TYPE A
Active strength
100 [USP'U]/1
Pharmacologic classes
Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Jeuveau
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOTULINUM TOXIN TYPE A100 [USP'U]/1

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
2117871Internal RxNorm lookup
2117876Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
17a914c1-e54b-4b50-965d-b0fd9111bba4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2a92e090-adb9-48d2-ae5f-5956e4b6ad90Product name120231024
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
525448fb-6d30-4c07-bb80-9a8499bd8113Product name120230627
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0cf2215a-e8b6-4688-9989-d0fcd154e4b8Product name120170725
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8c498f95-3b71-4acf-9882-f567b5cc4a2aProduct name120160208
e9681bd0-ddf1-421f-88c4-4337e89d5421Product name120160208
a42a1284-ee26-4b9f-a2b3-1ba05f250710Product name120151202
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72301-595-10Jeuveau1 in 1 CARTONPOWDER18
72301-595-10Jeuveau1 in 1 VIALPOWDER18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72301-595-10EA - Each72301-5958b41dece-e882-48f7-81bb-fa5c2aa73de112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72301-595JEUVEAU (PRABOTULINUM TOXIN TYPE A) POWDER [EVOLUS, INC.]8Current NDC, Legacy NDC, 2 package rows20231214_17a914c1-e54b-4b50-965d-b0fd9111bba4.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
JeuveauPRABOTULINUM TOXIN TYPE AEvolus, Inc.17a914c1-e54b-4b50-965d-b0fd9111bba42023-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761085
ndc (product): 72301-595

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761085JeuveauprabotulinumtoxinA-xvfs351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2117876Jeuveau 100 UNT InjectionPSN17a914c1-e54b-4b50-965d-b0fd9111bba48
2117871prabotulinumtoxinA-xvfs 100 UNT InjectionPSN17a914c1-e54b-4b50-965d-b0fd9111bba48
2117876prabotulinumtoxinA-xvfs 100 UNT Injection [Jeuveau]SBD17a914c1-e54b-4b50-965d-b0fd9111bba48
2117871prabotulinumtoxinA-xvfs 100 UNT InjectionSCD17a914c1-e54b-4b50-965d-b0fd9111bba48
2117876Jeuveau 100 UNT InjectionSY17a914c1-e54b-4b50-965d-b0fd9111bba48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72301-595-10723010595101 VIAL in 1 CARTON (72301-595-10) / 1 POWDER in 1 VIAL1 vial2019-02-130000-00-00NoNoCurrent