NDC Code(s) : 0023-3919-50, 0023-3919-51, 0023-9232-02, 0023-9232-01
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BOTOX CosmeticonabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-3919
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTULINUM TOXIN TYPE A(UNII: E211KPY694)
(BOTULINUM TOXIN TYPE A - UNII:E211KPY694) 		BOTULINUM TOXIN TYPE A50 [USP'U]
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN(UNII: ZIF514RVZR)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0023-3919-501 in 1 CARTON 15/07/2008
11 in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:0023-3919-511 in 1 CARTON 15/07/2008
21 in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103000 07/15/2008
BOTOX CosmeticonabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-9232
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTULINUM TOXIN TYPE A(UNII: E211KPY694)
(BOTULINUM TOXIN TYPE A - UNII:E211KPY694) 		BOTULINUM TOXIN TYPE A100 [USP'U]
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN(UNII: ZIF514RVZR)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0023-9232-021 in 1 CARTON 20/05/2008
11 in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:0023-9232-011 in 1 CARTON 20/05/2008
21 in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103000 05/20/2008

LABELER - Allergan, Inc.(144796497)

PRINCIPAL DISPLAY PANEL

NDC 0023-3919-50

BOTOX ®
COSMETIC
onabotulinumtoxinA
for Injection
50
Units/vial

Allergan

Aesthetics

An AbbVie Company

Dispense the accompanying

Medication Guide to each patient.

NDC 0023-3919-50 Botox Cosmetic onabotulinumtoxinA for Injection 50 Units/Vial

PRINCIPAL DISPLAY PANEL

NDC 0023-9232-01

BOTOX ®
COSMETIC
onabotulinumtoxinA
for Injection
100
Units/Vial

Allergan

Aesthetics

An AbbVie company

Dispense the accompanying

Medication Guide to each patient.

NDC 0023-9232-50 Botox Cosmetic onabotulinumtoxinA for Injection 100 Units/Vial