Prescription drug · ANDA
Quinidine gluconate (quinidine gluonate) NDC 71930-016
Quinidine gluconate 324 mg/1 · Tablet, Extended release · Oral · Eywa Pharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71930-016-12 | 71930001612 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12)Marketed from Mar 20, 2022 |
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 gluonate
- Active ingredients
- Quinidine gluconate — 324 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Eywa Pharma Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212589
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)
- Identifiers
- Product ID 71930-016_d4e8ed08-f426-4fdb-9dd3-d46730e9f81bSPL ID d4e8ed08-f426-4fdb-9dd3-d46730e9f81bSPL set ID 4db375a3-0cff-4fa7-af7a-2a49e0b922d0RxCUI 852920UNII R6875N380FUPC 0371930016127
- 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
N471930001612followed by a unit qualifier and the quantityPackage 71930-0016-12. 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 .
Indications (excerpt from the label)
INDICATIONS & 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 had…
Excerpt only. Read the full label for complete information.