Prescription drug · ANDA
Ibutilide Fumarate NDC 23155-326
Ibutilide fumarate 1 mg/10mL · Injection, Solution · Intravenous · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-326-31 | 2315503263123155032631 | 1 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASSMarketed from Apr 1, 2024 |
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)
- Ibutilide Fumarate
- Generic name (nonproprietary)
- ibutilide fumarate
- Active ingredients
- Ibutilide fumarate — 1 mg/10mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDC labeler code 23155
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204146
- Marketing start
- Listing expires
- Identifiers
- Product ID 23155-326_d27fccf1-d015-47a7-9fff-2d028495a1fcSPL ID d27fccf1-d015-47a7-9fff-2d028495a1fcSPL set ID 0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd0RxCUI 979120UNII 9L5X4M5L6IUPC 0323155326314
- Pharmacologic class
- Antiarrhythmic
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 codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- 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
N423155032631followed by a unit qualifier and the quantityPackage 23155-0326-31. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Ibutilide fumarate injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to ibutilide fumarate. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration. LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT Ibutilide fumarate can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In registration s…
Excerpt only. Read the full label for complete information.
About NDC 23155-326
- What is NDC 23155-326?
- 23155-326 is the product NDC for Ibutilide Fumarate, Ibutilide fumarate 1 mg/10mL injection, solution, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibutilide Fumarate.
- What is the active ingredient?
- Ibutilide fumarate.
- Who is the labeler?
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 23155. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibutilide Fumarate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.