Propafenone Hydrochloride
- Product NDC
- 70771-1527
- 11-digit product format
- 707711527
- Labeler code
- 70771
- Product ID
- 70771-1527_e7389f3e-074b-44ca-b767-5520390265e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propafenone Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA214184
- Marketing category
- ANDA
- Marketing start
- 2022-02-02
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 425 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 33XCH0HOCD | PROPAFENONE HYDROCHLORIDE | 34183-22-7 | PROPAFENONE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1527-5 | 70771152705 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1527-5) | 2022-02-02 | No | No | Historical |
| 70771-1527-6 | 70771152706 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1527-6) | 2022-02-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Propafenone Hydrochloride | Zydus Lifesciences Limited | 2023-12-11 | HUMAN PRESCRIPTION DRUG LABEL | 2 |