NDC codes

FDA NDC Directory
Product NDC (as listed)0023-9232Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00023-9232Add 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 NDC11-digit (billing)PackageCopy
0023-9232-01000239232011 VIAL, GLASS in 1 CARTON (0023-9232-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASSMarketed from May 20, 2008
0023-9232-02000239232021 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 a100 [USP'U]/1
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intramuscular
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.

How CPT relates to drug billing

NDC on a medical claim

N400023923201 followed by a unit qualifier and the quantity

Package 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.

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
ProductStrengthForm · routeLabelerProduct NDC
BotoxonabotulinumtoxinaBotulinum toxin type a 100 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntradermal, IntramuscularAllergan, Inc.0023-1145
BOTOX CosmeticonabotulinumtoxinaBotulinum toxin type a 50 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscularAllergan, Inc.0023-3919
BotoxonabotulinumtoxinaBotulinum toxin type a 200 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntradermal, IntramuscularAllergan, Inc.0023-3921
BotoxonabotulinumtoxinaBotulinum toxin type a 100 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntradermal, IntramuscularSportpharm LLC85766-155

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