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 NDC11-digit (billing)PackageCopy
51407-288-015140702880151407028801100 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

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 . 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)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Quinidine Gluconate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Quinidine gluconatequinidine gluonateQuinidine gluconate 324 mg/1Tablet, Extended releaseOralEywa Pharma Inc71930-01671930-0016-12
Quinidine GluconateQuinidine gluconate 324 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc.53489-14153489-0141-0153489-0141-0353489-0141-05+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.

FDA NDC Directory listings under ANDA 089338
ProductStrengthForm · routeLabelerProduct NDC
Quinidine GluconateQuinidine gluconate 324 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc.53489-141

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in