Prescription drug · ANDA
Propafenone Hydrochloride (Propafenone) NDC 69680-132
Propafenone hydrochloride 425 mg/1 · Capsule, Extended release · Oral · Vitruvias Therapeutics
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69680-132-60 | 6968001326069680013260 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-132-60)Marketed from Jan 28, 2019 | |
| 69680-132-92 | 6968001329269680013292 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-132-92)Marketed from Jan 28, 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)
- Propafenone Hydrochloride
- Generic name (nonproprietary)
- propafenone
- Active ingredients
- Propafenone hydrochloride — 425 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Vitruvias TherapeuticsNDC labeler code 69680
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210339
- Marketing start
- Listing expires
- Identifiers
- Product ID 69680-132_827a5fb5-9318-4116-9e23-6b75e469dd77SPL ID 827a5fb5-9318-4116-9e23-6b75e469dd77SPL set ID bc1d2548-15a3-4986-92b1-c3ddfb35343aRxCUI 861156, 861164, 861171UNII 33XCH0HOCDUPC 0369680132600, 0369680130606, 0369680130927, 0369680132921, 0369680131924, 0369680131603
- Pharmacologic class
- Antiarrhythmic
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
N469680013260followed by a unit qualifier and the quantityPackage 69680-0132-60. 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)
Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF. Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase i…
Excerpt only. Read the full label for complete information.
About NDC 69680-132
- What is NDC 69680-132?
- 69680-132 is the product NDC for Propafenone Hydrochloride (propafenone), Propafenone hydrochloride 425 mg/1 capsule, extended release, listed with the FDA by Vitruvias Therapeutics. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Propafenone Hydrochloride (Propafenone).
- What is the active ingredient?
- Propafenone hydrochloride.
- Who is the labeler?
- Vitruvias Therapeutics, NDC labeler code 69680. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Propafenone Hydrochloride?
- 52 other product NDCs are listed under this name. See all Propafenone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Propafenone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-930 | 60687-0930-01 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-246 | 64380-0246-01 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-268 | 64380-0268-0164380-0268-02 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-269 | 64380-0269-0164380-0269-02 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-276 | 59651-0276-0559651-0276-6059651-0276-90 |
| Propafenone Hydrochloride | Propafenone hydrochloride 325 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-277 | 59651-0277-0559651-0277-6059651-0277-90 |
| Propafenone Hydrochloride | Propafenone hydrochloride 425 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-278 | 59651-0278-0559651-0278-6059651-0278-90 |
| Propafenone Hydrochloride | Propafenone hydrochloride 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-709 | 60687-0709-01 |
| Propafenone Hydrochloride | Propafenone hydrochloride 300 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-163 | 64380-0163-01 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-164 | 64380-0164-0164380-0164-02 |
Other NDCs under ANDA 210339
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 |
|---|---|---|---|---|
| Propafenone Hydrochloridepropafenone | Propafenone hydrochloride 225 mg/1 | Capsule, Extended releaseOral | Vitruvias Therapeutics | 69680-130 |
| Propafenone Hydrochloridepropafenone | Propafenone hydrochloride 325 mg/1 | Capsule, Extended releaseOral | Vitruvias Therapeutics | 69680-131 |