PROPAFENONE HYDROCHLORIDE
- Product NDC
- 53489-552
- 11-digit product format
- 534890552
- Labeler code
- 53489
- Product ID
- 53489-552_90501597-9f9b-483d-a46b-7e60c7b45cad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propafenone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA075998
- Marketing category
- ANDA
- Marketing start
- 2001-11-29
- Marketing end
- 0000-00-00
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 225 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 HYDROCHLORIDE | ACTIVE INGREDIENT | 33XCH0HOCD | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| PROPAFENONE | ACTIVE MOIETY | 68IQX3T69U | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
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 |
|---|
| 53489-552-01 | 53489055201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-552-01) | 2001-11-29 | 0000-00-00 | No | No | Current |
| 53489-552-03 | 53489055203 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-552-03) | 2001-11-29 | 0000-00-00 | No | No | Current |
| 53489-552-05 | 53489055205 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-552-05) | 2001-11-29 | 0000-00-00 | No | No | Current |
| 53489-552-07 | 53489055207 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-552-07) | 2001-11-29 | 0000-00-00 | No | No | Current |
| 53489-552-10 | 53489055210 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-552-10) | 2001-11-29 | 0000-00-00 | No | No | Current |