Prescription drug · ANDA
Disopyramide Phosphate NDC 75907-027
Disopyramide phosphate 100 mg/1 · Capsule · Oral · Dr. Reddy's Labratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-027-01 | 75907002701 | 100 CAPSULE in 1 BOTTLE (75907-027-01)Marketed from Mar 15, 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)
- Disopyramide Phosphate
- Generic name (nonproprietary)
- disopyramide phosphate
- Active ingredients
- Disopyramide phosphate — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr. Reddy's Labratories Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070173
- Marketing start
- Listing expires
- Identifiers
- Product ID 75907-027_d7fbded1-6b38-2f8c-f5ab-61e6a27f0787SPL ID d7fbded1-6b38-2f8c-f5ab-61e6a27f0787SPL set ID 3acbcef2-04ec-1ab1-b855-d1244b0e8006RxCUI 309958, 309960UNII N6BOM1935WUPC 0375907026010, 0375907027017
- 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
N475907002701followed by a unit qualifier and the quantityPackage 75907-0027-01. 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 capsules are 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, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide 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 arrhythmias.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070173
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 |
|---|---|---|---|---|
| Disopyramide Phosphate | Disopyramide phosphate 150 mg/1 | CapsuleOral | Dr. Reddy's Labratories Inc. | 75907-026 |