Prescription drug · BLA
BOTOX Cosmetic (onabotulinumtoxina) NDC 0023-9232
Botulinum toxin type a 100 [USP'U]/1 · Injection, Powder, Lyophilized, For solution · Intramuscular · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-9232-01 | 00023923201 | 1 VIAL, GLASS in 1 CARTON (0023-9232-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASSMarketed from May 20, 2008 | |
| 0023-9232-02 | 00023923202 | 1 VIAL, GLASS in 1 CARTON (0023-9232-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASSMarketed from May 20, 2008 |
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 Cosmetic
- Generic name (nonproprietary)
- onabotulinumtoxina
- Active ingredients
- Botulinum toxin type a — 100 [USP'U]/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular
- Labeler
- Allergan, Inc.
- 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 0023-9232_265710db-c7b9-42ff-9fc8-c24a936c1d87SPL ID 265710db-c7b9-42ff-9fc8-c24a936c1d87SPL set ID 485d9b71-6881-42c5-a620-a4360c7192abRxCUI 860192, 1726293, 1726296, 1726313UNII E211KPY694UPC 0300239232013
- 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
N400023923201followed by a unit qualifier and the quantityPackage 00023-9232-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of: • moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity • moderate to severe lateral canthal lines associated with orbicularis oculi activity • moderate to severe forehead lines associated with frontalis muscle activity • moderate to severe platysma bands associated with platysma muscle activity BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of ( 1 ): Moderate to severe glabellar lines associated with corrugator and/or p…
Excerpt only. Read the full label for complete information.
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 |
| 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 |
| Botoxonabotulinumtoxina | Botulinum toxin type a 100 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntradermal, Intramuscular | Sportpharm LLC | 85766-155 |
- Source
- FDA NDC Directory via openFDA; FDA SPL via openFDA and DailyMed; Med-Code HCPCS directory (curated)
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.