Prescription drug · ANDA
Quinidine Gluconate NDC 51407-288
Quinidine gluconate 324 mg/1 · Tablet, Extended release · Oral · Golden State Medical Supply
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-288-01 | 5140702880151407028801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-288-01)Marketed from Oct 24, 2019 |
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
- Labeler
- Golden State Medical SupplyNDC labeler code 51407
- 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 51407-288_20ac158b-a19f-cd3c-e063-6394a90a0c49SPL ID 20ac158b-a19f-cd3c-e063-6394a90a0c49SPL set ID ad2ad985-cca2-25b5-e053-2995a90a402fRxCUI 852920UNII R6875N380F
- 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
N451407028801followed by a unit qualifier and the quantityPackage 51407-0288-01. 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.
About NDC 51407-288
- What is NDC 51407-288?
- 51407-288 is the product NDC for Quinidine Gluconate, Quinidine gluconate 324 mg/1 tablet, extended release, listed with the FDA by Golden State Medical Supply. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quinidine Gluconate.
- What is the active ingredient?
- Quinidine gluconate.
- Who is the labeler?
- Golden State Medical Supply, NDC labeler code 51407. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quinidine Gluconate?
- 2 other product NDCs are listed under this name. See all Quinidine Gluconate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quinidine Gluconate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quinidine gluconatequinidine gluonate | Quinidine gluconate 324 mg/1 | Tablet, Extended releaseOral | Eywa Pharma Inc | 71930-016 | 71930-0016-12 |
| Quinidine Gluconate | Quinidine gluconate 324 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 53489-141 | 53489-0141-0153489-0141-0353489-0141-05+4 more |
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 | Sun Pharmaceutical Industries, Inc. | 53489-141 |