NDC Code(s) : 0023-1145-01, 0023-1145-02, 0023-3921-02, 0023-3921-03
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BOTOXonabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-1145
Route of Administration INTRADERMAL, 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)0.5 mg in 1 1
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.9 mg in 1 1
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0023-1145-011 in 1 CARTON 15/12/1989
11 in 1 VIAL Type 0: Not a Combination Product
2NDC:0023-1145-021 in 1 CARTON 15/12/1989
21 in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103000 12/15/1989
BOTOXonabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-3921
Route of Administration INTRADERMAL, 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 A200 [USP'U]
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN(UNII: ZIF514RVZR)1 mg in 1 1
SODIUM CHLORIDE(UNII: 451W47IQ8X)1.8 mg in 1 1
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0023-3921-021 in 1 CARTON 01/11/2010
11 in 1 VIAL Type 0: Not a Combination Product
2NDC:0023-3921-031 in 1 CARTON 01/11/2010
21 in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103000 01/11/2010

LABELER - Allergan, Inc.(144796497)

PRINCIPAL DISPLAY PANEL

NDC 0023-1145-01
OnabotulinumtoxinA
BOTOX®
for injection
100 Units/vial

abbvie

PRINCIPAL DISPLAY PANEL NDC 0023-1145-01 OnabotulinumtoxinA BOTOX® for injection 100 Units/vial abbvie

PRINCIPAL DISPLAY PANEL

NDC 0023-3921-02


OnabotulinumtoxinA
BOTOX®
for injection
200 Units/vial

abbvie

PRINCIPAL DISPLAY PANEL NDC 0023-3921-02 OnabotulinumtoxinA BOTOX® for injection 200 Units/vial abbvie