Botox (onabotulinumtoxina) NDC 85766-155

NDC codes

FDA NDC Directory

Product NDC (as listed)85766-155Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85766-0155Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
85766-155-01	85766015501	1 VIAL in 1 CARTON (85766-155-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Feb 3, 2026
85766-155-02	85766015502	1 VIAL in 1 CARTON (85766-155-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Feb 3, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Botox
Generic name (nonproprietary): onabotulinumtoxina
Active ingredients: Botulinum toxin type a — 100 [USP'U]/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intradermal, Intramuscular
Labeler: Sportpharm LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 103000
Marketing start: Dec 15, 1989
Listing expires: Dec 31, 2027
Other FDA classes: Acetylcholine Release Inhibitors (Mechanism)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 85766-155_49e53ae0-1a1f-ec83-e063-6394a90a2c8dSPL ID 49e53ae0-1a1f-ec83-e063-6394a90a2c8dSPL set ID a6f42753-d31e-4b23-8da0-4b990fee4b38RxCUI 860192, 860195UNII E211KPY694
Pharmacologic class: Acetylcholine Release Inhibitor; Neuromuscular Blocker

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeMed-Code curated

J0585 — Injection, onabotulinumtoxinA, 1 unit

Billing unit: 1 unit. Units on the claim = dose given ÷ 1 unit.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N485766015501 followed by a unit qualifier and the quantity

Package 85766-0155-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication ( 1.1 ) Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication ( 1.1 ) Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 103000

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 103000
Product	Strength	Form · route	Labeler	Product NDC
Botoxonabotulinumtoxina	Botulinum toxin type a 100 [USP'U]/1	Injection, Powder, Lyophilized, For solutionIntradermal, Intramuscular	Allergan, Inc.	0023-1145
BOTOX Cosmeticonabotulinumtoxina	Botulinum toxin type a 50 [USP'U]/1	Injection, Powder, Lyophilized, For solutionIntramuscular	Allergan, Inc.	0023-3919
Botoxonabotulinumtoxina	Botulinum toxin type a 200 [USP'U]/1	Injection, Powder, Lyophilized, For solutionIntradermal, Intramuscular	Allergan, Inc.	0023-3921
BOTOX Cosmeticonabotulinumtoxina	Botulinum toxin type a 100 [USP'U]/1	Injection, Powder, Lyophilized, For solutionIntramuscular	Allergan, Inc.	0023-9232