Prescription drug · ANDA
Quinidine Gluconate NDC 53489-141
Quinidine gluconate 324 mg/1 · Tablet, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53489-141-01 | 53489014101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01)Marketed from Feb 10, 1987 | |
| 53489-141-03 | 53489014103 | 250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-03)Marketed from Feb 10, 1987 | |
| 53489-141-05 | 53489014105 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-05)Marketed from Feb 10, 1987 | |
| 53489-141-06 | 53489014106 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06)Marketed from Feb 10, 1987 | |
| 53489-141-07 | 53489014107 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07)Marketed from Feb 10, 1987 | |
| 53489-141-10 | 53489014110 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-10)Marketed from Feb 10, 1987 | |
| 53489-141-90 | 53489014190 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-90)Marketed from Feb 10, 1987 |
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)
- Quinidine Gluconate
- Generic name (nonproprietary)
- quinidine gluconate
- Active ingredients
- Quinidine gluconate — 324 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089338
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)
- Identifiers
- Product ID 53489-141_47cec250-341a-4694-a232-93106833a75eSPL ID 47cec250-341a-4694-a232-93106833a75eSPL set ID 5023f053-fcc4-4c2c-aa59-9ec198ad185eRxCUI 852920UNII R6875N380FUPC 0353489141017
- Pharmacologic class
- Antiarrhythmic; Cytochrome P450 2D6 Inhibitor
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
N453489014101followed by a unit qualifier and the quantityPackage 53489-0141-01. 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 Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION ), then quinidine gluconate should be discontinued. Reduction of frequency of relapse into atrial fibrillation/flutter Chronic therapy with quinidine gluconate is indicated for some patients at high risk of symptomatic atrial fibrillation/flutter, generally patients who have h…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 089338
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 |
|---|---|---|---|---|
| Quinidine Gluconate | Quinidine gluconate 324 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply | 51407-288 |