NDC 0023-3919

BOTOX Cosmetic

Onabotulinumtoxina

BOTOX Cosmetic is a Intramuscular Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Botulinum Toxin Type A.

• Product ID: 0023-3919_03473e87-ca9a-41fc-8f37-ae44eaf50635
• NDC: 0023-3919
• Product Type: Human Prescription Drug
• Proprietary Name: BOTOX Cosmetic
• Generic Name: Onabotulinumtoxina
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2008-07-15
• Marketing Category: BLA / BLA
• Application Number: BLA103000
• Labeler Name: Allergan, Inc.
• Substance Name: BOTULINUM TOXIN TYPE A
• Active Ingredient Strength: 50 [USP'U]/1
• Pharm Classes: Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0023-3919-50

1 VIAL, GLASS in 1 CARTON (0023-3919-50) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

• Marketing Start Date: 2008-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-3919-51 [00023391951]

BOTOX Cosmetic INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103000
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-07-15

NDC 0023-3919-50 [00023391950]

BOTOX Cosmetic INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103000
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-07-15

Drug Details

Active Ingredients

Ingredient	Strength
BOTULINUM TOXIN TYPE A	50 [USP'U]/1

OpenFDA Data

• SPL SET ID: 485d9b71-6881-42c5-a620-a4360c7192ab
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • E211KPY694
• RxNorm Concept Unique ID - RxCUI:
  • 860192
  • 1726296
  • 1726313
  • 1726293
• UPC Code:
  • 0300239232013
  • 0300233919507

Pharmacological Class

• Acetylcholine Release Inhibitor [EPC]
• Acetylcholine Release Inhibitors [MoA]

NDC Crossover Matching brand name "BOTOX Cosmetic" or generic name "Onabotulinumtoxina"

NDC	Brand Name	Generic Name
0023-3919	BOTOX Cosmetic	onabotulinumtoxinA
0023-9232	BOTOX Cosmetic	onabotulinumtoxinA
0023-1145	BOTOX	onabotulinumtoxinA
0023-3921	BOTOX	onabotulinumtoxinA