FDA.reportPublic FDA data

BOTOX Cosmetic

Product NDC
0023-3919
11-digit product format
000233919
Labeler code
0023
Product ID
0023-3919_265710db-c7b9-42ff-9fc8-c24a936c1d87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
onabotulinumtoxinA
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Allergan, Inc.
Application
BLA103000
Marketing category
BLA
Marketing start
2008-07-15
Substance
BOTULINUM TOXIN TYPE A
Active strength
50 [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 Cosmetic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOTULINUM TOXIN TYPE A50 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE211KPY694
Rxcui860192, 1726293, 1726296, 1726313

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
0023-3919-50BOTOX Cosmetic1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,154
0023-3919-50BOTOX Cosmetic1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,154
0023-3919-51BOTOX Cosmetic1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,154
0023-3919-51BOTOX Cosmetic1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3919-50EA - Each0023-391951957bfd-b856-467a-a7ea-e1109d192ed512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
botulinum toxin type AACTIVE INGREDIENTE211KPY694BOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]21
botulinum toxin type AACTIVE MOIETYE211KPY694BOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]21
Albumin HumanINACTIVE INGREDIENTZIF514RVZRBOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]21
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XBOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3919BOTOX COSMETIC (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]52Current NDC, Legacy NDC, 4 package rows20241031_485d9b71-6881-42c5-a620-a4360c7192ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726313BOTOX Cosmetic 100 UNT InjectionPSN485d9b71-6881-42c5-a620-a4360c7192ab54
1726296BOTOX Cosmetic 50 UNT InjectionPSN485d9b71-6881-42c5-a620-a4360c7192ab54
860192onabotulinumtoxinA 100 UNT InjectionPSN485d9b71-6881-42c5-a620-a4360c7192ab54
1726293onabotulinumtoxinA 50 UNT InjectionPSN485d9b71-6881-42c5-a620-a4360c7192ab54
1726313onabotulinumtoxinA 100 UNT Injection [Botox Cosmetic]SBD485d9b71-6881-42c5-a620-a4360c7192ab54
1726296onabotulinumtoxinA 50 UNT Injection [Botox Cosmetic]SBD485d9b71-6881-42c5-a620-a4360c7192ab54
860192onabotulinumtoxinA 100 UNT InjectionSCD485d9b71-6881-42c5-a620-a4360c7192ab54
1726293onabotulinumtoxinA 50 UNT InjectionSCD485d9b71-6881-42c5-a620-a4360c7192ab54
1726313Botox Cosmetic 100 UNT InjectionSY485d9b71-6881-42c5-a620-a4360c7192ab54
1726296Botox Cosmetic 50 UNT InjectionSY485d9b71-6881-42c5-a620-a4360c7192ab54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-3919-50000233919501 VIAL, GLASS in 1 CARTON (0023-3919-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2008-07-150000-00-00NoNoCurrent
0023-3919-51000233919511 VIAL, GLASS in 1 CARTON (0023-3919-51) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2008-07-150000-00-00YesNoCurrent