Prescription drug · NDA
Norpace (disopyramide phosphate) NDC 0025-2762
Disopyramide phosphate 150 mg/1 · Capsule, Gelatin coated · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0025-2762-31 | 00025276231 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2762-31)Marketed from Sep 1, 1977 |
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)
- Norpace
- Generic name (nonproprietary)
- disopyramide phosphate
- Active ingredients
- Disopyramide phosphate — 150 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017447
- Marketing start
- Listing expires
- Identifiers
- Product ID 0025-2762_6790ba4d-7819-4ed5-96d9-2126ef99f109SPL ID 6790ba4d-7819-4ed5-96d9-2126ef99f109SPL set ID e2aa1642-d262-4520-bc6a-9fd3ad795677RxCUI 209066, 209692, 309958, 309960, 636793, 636794, 902648, 902652UNII N6BOM1935WUPC 0300252752314, 0300252762313, 0300252742315, 0300252732316
- 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
N400025276231followed by a unit qualifier and the quantityPackage 00025-2762-31. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Norpace and Norpace CR 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 Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma level…
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 |
| Disopyramide Phosphate | Disopyramide phosphate 100 mg/1 | Capsule, Gelatin coatedOral | Mylan Pharmaceuticals Inc. | 59762-0386 |
| Disopyramide Phosphate | Disopyramide phosphate 150 mg/1 | Capsule, Gelatin coatedOral | Mylan Pharmaceuticals Inc. | 59762-0400 |