Prescription drug · BLA
Botox (Onabotulinumtoxina) NDC 0023-3921
Botulinum toxin type a 200 [USP'U]/1 · Injection, Powder, Lyophilized, For solution · Intradermal, Intramuscular · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-3921-02 | 0002339210200023392102 | 1 VIAL in 1 CARTON (0023-3921-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Jan 11, 2010 | |
| 0023-3921-03 | 0002339210300023392103 | 1 VIAL in 1 CARTON (0023-3921-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Jan 11, 2010 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 [USP'U]/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intradermal, Intramuscular
- Labeler
- Allergan, Inc.NDC labeler code 0023
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103000
- Marketing start
- Listing expires
- Other FDA classes
- Acetylcholine Release Inhibitors (Mechanism)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 0023-3921_9adba2d4-2c32-4986-a1b6-bcc17d5326d1SPL ID 9adba2d4-2c32-4986-a1b6-bcc17d5326d1SPL set ID 33d066a9-34ff-4a1a-b38b-d10983df3300RxCUI 860192, 860195, 897366, 897368UNII 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.
- NDC on a medical claim
N400023392102followed by a unit qualifier and the quantityPackage 00023-3921-02. 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 . 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.
About NDC 0023-3921
- What is NDC 0023-3921?
- 0023-3921 is the product NDC for Botox (onabotulinumtoxina), Botulinum toxin type a 200 [USP'U]/1 injection, powder, lyophilized, for solution, listed with the FDA by Allergan, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Botox (OnabotulinumtoxinA).
- What is the active ingredient?
- Botulinum toxin type a.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Botox?
- 2 other product NDCs are listed under this name. See all Botox NDCs.
- Is there a related HCPCS / J-code?
- Yes: J0585, Injection, onabotulinumtoxinA, 1 unit. See Billing references above.
Related NDCs: other Botox products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Botoxonabotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntradermal, Intramuscular | Allergan, Inc. | 0023-1145 | 00023-1145-0100023-1145-02 |
| Botoxonabotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntradermal, Intramuscular | Sportpharm LLC | 85766-155 | 85766-0155-0185766-0155-02 |
Other NDCs under BLA 103000
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |
| Botoxonabotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntradermal, Intramuscular | Sportpharm LLC | 85766-155 |
| BOTOX Cosmeticonabotulinumtoxina | Botulinum toxin type a 50 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Allergan, Inc. | 0023-3919 |
| BOTOX Cosmeticonabotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular | Allergan, Inc. | 0023-9232 |