Propafenone Hydrochloride
- Product NDC
- 49884-210
- 11-digit product format
- 498840210
- Labeler code
- 49884
- Product ID
- 49884-210_b87c7717-5019-43fe-9a18-d2d7ae07cc91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propafenone hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA078540
- Marketing category
- ANDA
- Marketing start
- 2011-01-03
- Marketing end
- 0000-00-00
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 325 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROPAFENONE | ACTIVE INGREDIENT | 68IQX3T69U | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPAFENONE | ACTIVE MOIETY | 68IQX3T69U | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| ETHANOL | INACTIVE INGREDIENT | 3K9958V90M | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE BLACK | INACTIVE INGREDIENT | XM0M87F357 | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-210-01 | 49884021001 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-01) | 2011-01-03 | 0000-00-00 | No | No | Current |
| 49884-210-02 | 49884021002 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-02) | 2011-01-03 | 2024-09-30 | No | No | Current |
| 49884-210-05 | 49884021005 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-05) | 2011-01-03 | 2023-12-31 | No | No | Current |
| 49884-210-09 | 49884021009 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-09) | 2011-01-03 | 2024-09-30 | No | No | Current |
| 49884-210-10 | 49884021010 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-10) | 2011-01-03 | 0000-00-00 | No | No | Current |