FDA.reportPublic FDA data

BOTOX

Product NDC
0023-1145
11-digit product format
000231145
Labeler code
0023
Product ID
0023-1145_7365af65-15e0-4fc1-aa6a-aaec5a43c468
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
onabotulinumtoxinA
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRADERMAL; INTRAMUSCULAR
Labeler
Allergan, Inc.
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
2026-12-31
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 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860192Internal RxNorm lookup
860195Internal RxNorm lookup
897366Internal RxNorm lookup
897368Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33d066a9-34ff-4a1a-b38b-d10983df3300Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-1145-01BOTOX1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,161
0023-1145-01BOTOX1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,161
0023-1145-02BOTOX1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,161
0023-1145-02BOTOX1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,161

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-1145-01EA - Each0023-114512185aac-6cce-479d-8ab2-03ca0449cbfc12012-07-24
0023-1145-02EA - Each0023-114555566931-569c-4241-82b4-4df8b3bf870d12023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
botulinum toxin type AACTIVE INGREDIENTE211KPY694BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC. ]24
botulinum toxin type AACTIVE MOIETYE211KPY694BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC. ]24
Albumin (Human)INACTIVE INGREDIENTZIF514RVZRBOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC. ]24
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XBOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC. ]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-1145BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.]59Current NDC, Legacy NDC, 4 package rows20241101_33d066a9-34ff-4a1a-b38b-d10983df3300.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BOTOXONABOTULINUMTOXINASportpharm LLCa6f42753-d31e-4b23-8da0-4b990fee4b382026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103000
BOTOX CosmeticONABOTULINUMTOXINAAllergan, Inc.485d9b71-6881-42c5-a620-a4360c7192ab2024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103000
BOTOXONABOTULINUMTOXINAAllergan, Inc.33d066a9-34ff-4a1a-b38b-d10983df33002023-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103000
ndc (product): 0023-1145

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103000Botox CosmeticonabotulinumtoxinA351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860195Botox 100 UNT InjectionPSN33d066a9-34ff-4a1a-b38b-d10983df330061
897368Botox 200 UNT InjectionPSN33d066a9-34ff-4a1a-b38b-d10983df330061
860192onabotulinumtoxinA 100 UNT InjectionPSN33d066a9-34ff-4a1a-b38b-d10983df330061
897366onabotulinumtoxinA 200 UNT InjectionPSN33d066a9-34ff-4a1a-b38b-d10983df330061
860195onabotulinumtoxinA 100 UNT Injection [Botox]SBD33d066a9-34ff-4a1a-b38b-d10983df330061
897368onabotulinumtoxinA 200 UNT Injection [Botox]SBD33d066a9-34ff-4a1a-b38b-d10983df330061
860192onabotulinumtoxinA 100 UNT InjectionSCD33d066a9-34ff-4a1a-b38b-d10983df330061
897366onabotulinumtoxinA 200 UNT InjectionSCD33d066a9-34ff-4a1a-b38b-d10983df330061
860195Botox 100 UNT InjectionSY33d066a9-34ff-4a1a-b38b-d10983df330061
897368Botox 200 UNT InjectionSY33d066a9-34ff-4a1a-b38b-d10983df330061
897368Botox 200 UNT/ML Injectable SolutionSY33d066a9-34ff-4a1a-b38b-d10983df330061
897366onabotulinumtoxinA 20 UNT per 0.1 ML Injectable SolutionSY33d066a9-34ff-4a1a-b38b-d10983df330061
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 startMarketing endSampleExclude flagStatus
0023-1145-01000231145011 VIAL in 1 CARTON (0023-1145-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial1989-12-150000-00-00NoNoCurrent
0023-1145-02000231145021 VIAL in 1 CARTON (0023-1145-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial1989-12-150000-00-00NoNoCurrent