Prescription drug · ANDA
Quinidine Sulfate (Quinidine sulfate tablet) NDC 42806-512
Quinidine sulfate 300 mg/1 · Tablet · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-512-01 | 42806051201 | 100 TABLET in 1 BOTTLE (42806-512-01)Marketed from Dec 15, 2021 | |
| 42806-512-30 | 42806051230 | 30 TABLET in 1 BOTTLE (42806-512-30)Marketed from Jan 2, 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 Sulfate
- Generic name (nonproprietary)
- quinidine sulfate tablet
- Active ingredients
- Quinidine sulfate — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- EPIC PHARMA, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088072
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)
- Identifiers
- Product ID 42806-512_80df716e-b0d6-4b0f-b0f4-879874d7ed05SPL ID 80df716e-b0d6-4b0f-b0f4-879874d7ed05SPL set ID b0d6341b-d880-4f0b-8844-bc788c03004aRxCUI 852877, 852913UNII J13S2394HEUPC 0342806513309, 0342806512302
- 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
N442806051201followed by a unit qualifier and the quantityPackage 42806-0512-01. 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 .
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 sulfate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine sulfate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION ), then quinidine sulfate should be discontinued. Reduction of Frequency of Relapse Into Atrial Fibrillation/Flutter Chronic therapy with quinidine sulfate is indicated for some patients at high risk of symptomatic atrial fibrillation/flutter, generally patients who have had previ…
Excerpt only. Read the full label for complete information.
About NDC 42806-512
- What is NDC 42806-512?
- 42806-512 is the product NDC for Quinidine Sulfate (quinidine sulfate tablet), Quinidine sulfate 300 mg/1 tablet, listed with the FDA by EPIC PHARMA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quinidine Sulfate (Quinidine sulfate tablet).
- What is the active ingredient?
- Quinidine sulfate.
- Who is the labeler?
- EPIC PHARMA, LLC, NDC labeler code 42806. 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 Sulfate?
- 1 other product NDC are listed under this name. See all Quinidine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quinidine Sulfate 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 Sulfatequinidine sulfate tablet | Quinidine sulfate 200 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-513 | 42806-0513-0142806-0513-30 |
Other NDCs under ANDA 088072
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 Sulfatequinidine sulfate tablet | Quinidine sulfate 200 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-513 |