botox

Generic: onabotulinumtoxina

Labeler: sportpharm llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name botox
Generic Name onabotulinumtoxina
Labeler sportpharm llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRADERMAL INTRAMUSCULAR
Active Ingredients

botulinum toxin type a 100 [USP'U]/1

Manufacturer
Sportpharm LLC

Identifiers & Regulatory

Product NDC 85766-155
Product ID 85766-155_49e53ae0-1a1f-ec83-e063-6394a90a2c8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103000
Listing Expiration 2027-12-31
Marketing Start 1989-12-15

Pharmacologic Class

Established (EPC)
acetylcholine release inhibitor [epc] neuromuscular blocker [epc]
Mechanism of Action
acetylcholine release inhibitors [moa]
Physiologic Effect
neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85766155
Hyphenated Format 85766-155

Supplemental Identifiers

RxCUI
860192 860195
UNII
E211KPY694
NUI
N0000175771 N0000193962 N0000175731 N0000175770

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name botox (source: ndc)
Generic Name onabotulinumtoxina (source: ndc)
Application Number BLA103000 (source: ndc)
Routes
INTRADERMAL INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 [USP'U]/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (85766-155-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
  • 1 VIAL in 1 CARTON (85766-155-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (2)

85766-155-01 1 VIAL in 1 CARTON (85766-155-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 85766-155-02 1 VIAL in 1 CARTON (85766-155-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

botulinum toxin type a (100 [USP'U]/1)

Linked Drug Pages (1)

BOTOX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRADERMAL", "INTRAMUSCULAR"], "spl_id": "49e53ae0-1a1f-ec83-e063-6394a90a2c8d", "openfda": {"nui": ["N0000175771", "N0000193962", "N0000175731", "N0000175770"], "unii": ["E211KPY694"], "rxcui": ["860192", "860195"], "spl_set_id": ["a6f42753-d31e-4b23-8da0-4b990fee4b38"], "pharm_class_pe": ["Neuromuscular Blockade [PE]"], "pharm_class_epc": ["Acetylcholine Release Inhibitor [EPC]", "Neuromuscular Blocker [EPC]"], "pharm_class_moa": ["Acetylcholine Release Inhibitors [MoA]"], "manufacturer_name": ["Sportpharm LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (85766-155-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "85766-155-01", "marketing_start_date": "20260203"}, {"sample": false, "description": "1 VIAL in 1 CARTON (85766-155-02)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "85766-155-02", "marketing_start_date": "20260203"}], "brand_name": "BOTOX", "product_id": "85766-155_49e53ae0-1a1f-ec83-e063-6394a90a2c8d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Acetylcholine Release Inhibitor [EPC]", "Acetylcholine Release Inhibitors [MoA]", "Neuromuscular Blockade [PE]", "Neuromuscular Blocker [EPC]"], "product_ndc": "85766-155", "generic_name": "onabotulinumtoxinA", "labeler_name": "Sportpharm LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BOTOX", "active_ingredients": [{"name": "BOTULINUM TOXIN TYPE A", "strength": "100 [USP'U]/1"}], "application_number": "BLA103000", "marketing_category": "BLA", "marketing_start_date": "19891215", "listing_expiration_date": "20271231"}