Quinidine Gluconate NDC 51407-288

NDC codes

FDA NDC Directory

Product NDC (as listed)51407-288Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51407-0288Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
51407-288-01	51407028801	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 Supply
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089338
Marketing start: Feb 11, 1987
Listing expires: Dec 31, 2026
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

N451407028801 followed by a unit qualifier and the quantity

Package 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 Aug 27, 2024. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 089338

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 089338
Product	Strength	Form · route	Labeler	Product NDC
Quinidine Gluconate	Quinidine gluconate 324 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	53489-141