NDC 0023-3921

BOTOX

Onabotulinumtoxina

BOTOX is a Intradermal; 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: 0023-3921_03d9dd80-7656-4f9d-9760-59ac600ad1d3
• NDC: 0023-3921
• Product Type: Human Prescription Drug
• Proprietary Name: BOTOX
• Generic Name: Onabotulinumtoxina
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRADERMAL; INTRAMUSCULAR
• Marketing Start Date: 2010-01-11
• Marketing Category: BLA / BLA
• Application Number: BLA103000
• Labeler Name: Allergan, Inc.
• Substance Name: BOTULINUM TOXIN TYPE A
• Active Ingredient Strength: 200 [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 0023-3921-02

1 VIAL in 1 CARTON (0023-3921-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• Marketing Start Date: 2010-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-3921-02 [00023392102]

BOTOX INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103000
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-01-11

NDC 0023-3921-03 [00023392103]

BOTOX INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103000
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-01-11

Drug Details

Active Ingredients

Ingredient	Strength
BOTULINUM TOXIN TYPE A	200 [USP'U]/1

OpenFDA Data

• SPL SET ID: 33d066a9-34ff-4a1a-b38b-d10983df3300
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • E211KPY694
• RxNorm Concept Unique ID - RxCUI:
  • 860192
  • 897366
  • 897368
  • 860195

Pharmacological Class

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

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

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