Prescription drug · ANDA
Procainamide Hydrochloride NDC 65145-155
Procainamide hydrochloride 100 mg/mL · Injection, Solution · Intramuscular, Intravenous · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-155-10 | 65145015510 | 10 VIAL, MULTI-DOSE in 1 CARTON (65145-155-10) / 10 mL in 1 VIAL, MULTI-DOSE (65145-155-01)Marketed from Feb 17, 2025 |
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)
- Procainamide Hydrochloride
- Generic name (nonproprietary)
- procainamide hydrochloride
- Active ingredients
- Procainamide hydrochloride — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Caplin Steriles Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218674
- Marketing start
- Listing expires
- Identifiers
- Product ID 65145-155_b7308804-0dc7-4740-8041-1dd391f950a4SPL ID b7308804-0dc7-4740-8041-1dd391f950a4SPL set ID fcaa5e9a-3c8a-4796-aa87-626268b6cf60RxCUI 857886, 857962UNII SI4064O0LXUPC 0365145156013, 0365145155016, 0365145156105, 0365145155108
- 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
N465145015510followed by a unit qualifier and the quantityPackage 65145-0155-10. 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)
INDICATIONS & USAGE Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmia…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218674
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 |
|---|---|---|---|---|
| Procainamide Hydrochloride | Procainamide hydrochloride 500 mg/mL | Injection, SolutionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-156 |