FDA.reportPublic FDA data

BOTOX

Product NDC
85766-155
11-digit product format
857660155
Labeler code
85766
Product ID
85766-155_49e53ae0-1a1f-ec83-e063-6394a90a2c8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
onabotulinumtoxinA
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRADERMAL; INTRAMUSCULAR
Labeler
Sportpharm LLC
Application
BLA103000
Marketing category
BLA
Marketing start
1989-12-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE211KPY694
Rxcui860192, 860195

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-155-01BOTOX1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11
85766-155-01BOTOX1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
85766-155-02BOTOX1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11
85766-155-02BOTOX1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860195Botox 100 UNT InjectionPSNa6f42753-d31e-4b23-8da0-4b990fee4b381
860192onabotulinumtoxinA 100 UNT InjectionPSNa6f42753-d31e-4b23-8da0-4b990fee4b381
860195onabotulinumtoxinA 100 UNT Injection [Botox]SBDa6f42753-d31e-4b23-8da0-4b990fee4b381
860192onabotulinumtoxinA 100 UNT InjectionSCDa6f42753-d31e-4b23-8da0-4b990fee4b381
860195Botox 100 UNT InjectionSYa6f42753-d31e-4b23-8da0-4b990fee4b381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-155-01857660155011 VIAL in 1 CARTON (85766-155-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2026-02-03NoNoCurrent
85766-155-02857660155021 VIAL in 1 CARTON (85766-155-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2026-02-03NoNoCurrent