Prescription drug · NDA AUTHORIZED GENERIC
Disopyramide Phosphate NDC 59762-0386
Disopyramide phosphate 100 mg/1 · Capsule, Gelatin coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0386-1 | 59762038601 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (59762-0386-1)Marketed from Apr 23, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Disopyramide Phosphate
- Generic name (nonproprietary)
- disopyramide phosphate
- Active ingredients
- Disopyramide phosphate — 100 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 017447
- Marketing start
- Listing expires
- Identifiers
- Product ID 59762-0386_ea995a2c-b191-47d5-b4d8-863782880b38SPL ID ea995a2c-b191-47d5-b4d8-863782880b38SPL set ID 31e79459-107f-4d69-a163-90014f1c4772RxCUI 309958, 309960UNII N6BOM1935WUPC 0359762038616, 0359762040015
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459762038601followed by a unit qualifier and the quantityPackage 59762-0386-01. 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)
INDICATIONS AND USAGE Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide phosphate 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 arr…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 017447
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 |
|---|---|---|---|---|
| Norpacedisopyramide phosphate | Disopyramide phosphate 100 mg/1 | Capsule, Gelatin coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-2752 |
| Norpacedisopyramide phosphate | Disopyramide phosphate 150 mg/1 | Capsule, Gelatin coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-2762 |
| Disopyramide Phosphate | Disopyramide phosphate 150 mg/1 | Capsule, Gelatin coatedOral | Mylan Pharmaceuticals Inc. | 59762-0400 |