Prescription drug · ANDA
Propafenone Hydrochloride NDC 70771-1526
Propafenone hydrochloride 325 mg/1 · Capsule, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1526-5 | 7077115260570771152605 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1526-5)Marketed from Feb 2, 2022 | |
| 70771-1526-6 | 7077115260670771152606 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1526-6)Marketed from Feb 2, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride
- Active ingredients
- Propafenone hydrochloride — 325 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214184
- Marketing start
- Listing expires
- Identifiers
- Product ID 70771-1526_e7389f3e-074b-44ca-b767-5520390265e5SPL ID e7389f3e-074b-44ca-b767-5520390265e5SPL set ID b41ec863-5734-41a3-9837-6c0a962ec6ebRxCUI 861156, 861164, 861171UNII 33XCH0HOCDUPC 0370771152766
- 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
N470771152605followed by a unit qualifier and the quantityPackage 70771-1526-05. 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 are 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 …
Excerpt only. Read the full label for complete information.
About NDC 70771-1526
- What is NDC 70771-1526?
- 70771-1526 is the product NDC for Propafenone Hydrochloride, Propafenone hydrochloride 325 mg/1 capsule, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Propafenone Hydrochloride.
- What is the active ingredient?
- Propafenone hydrochloride.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 214184
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 Hydrochloride | Propafenone hydrochloride 225 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-522 |
| Propafenone Hydrochloride | Propafenone hydrochloride 325 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-523 |
| Propafenone Hydrochloride | Propafenone hydrochloride 425 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-524 |
| Propafenone Hydrochloride | Propafenone hydrochloride 225 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1525 |
| Propafenone Hydrochloride | Propafenone hydrochloride 425 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1527 |