Propafenone Hydrochloride
- Product NDC
- 0591-2285
- 11-digit product format
- 005912285
- Labeler code
- 0591
- Product ID
- 0591-2285_06e9ec6f-973a-4ec0-a08a-de7e3432409d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propafenone Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA202688
- Marketing category
- ANDA
- Marketing start
- 2015-10-15
- Marketing end
- 0000-00-00
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 225 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPAFENONE HYDROCHLORIDE | 225 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2285-00 | 00591228500 | 15065 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0591-2285-00) | 22-SEP-15 | | | | Current |
| 0591-2285-60 | 00591228560 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2285-60) | 2015-10-15 | 0000-00-00 | No | No | Current |