Flecainide Acetate
- Product NDC
- 71335-1487
- 11-digit product format
- 713351487
- Labeler code
- 71335
- Product ID
- 71335-1487_f0ea084d-e915-46dd-a726-56dbce934a27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flecainide Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075882
- Marketing category
- ANDA
- Marketing start
- 2015-12-28
- Substance
- FLECAINIDE ACETATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-1487_f0ea084d-e915-46dd-a726-56dbce934a27
- SPL ID
- f0ea084d-e915-46dd-a726-56dbce934a27
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Flecainide Acetate
- Generic name
- Flecainide Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2015-12-28
- Marketing category
- ANDA
- Application number
- ANDA075882
- Pharmacologic classes
- Antiarrhythmic [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| FLECAINIDE ACETATE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | M8U465Q1WQ |
| Rxcui | 886662 |
| Spl Set Id | f0416c8c-faae-4e31-aa50-1fb7df10abf0 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1487-1 | 30 TABLET in 1 BOTTLE (71335-1487-1) | 2020-01-17 | No |
| 71335-1487-2 | 60 TABLET in 1 BOTTLE (71335-1487-2) | 2020-03-19 | No |
| 71335-1487-3 | 90 TABLET in 1 BOTTLE (71335-1487-3) | 2021-12-28 | No |
| 71335-1487-4 | 10 TABLET in 1 BOTTLE (71335-1487-4) | 2021-12-28 | No |
| 71335-1487-5 | 180 TABLET in 1 BOTTLE (71335-1487-5) | 2025-09-23 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| M8U465Q1WQ | FLECAINIDE ACETATE | 54143-56-5 | FLECAINIDE ACETATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1487-1 | 71335148701 | 30 TABLET in 1 BOTTLE (71335-1487-1) | 30 tablet | 2020-01-17 | No | No | Historical |
| 71335-1487-2 | 71335148702 | 60 TABLET in 1 BOTTLE (71335-1487-2) | 60 tablet | 2020-03-19 | No | No | Historical |
| 71335-1487-3 | 71335148703 | 90 TABLET in 1 BOTTLE (71335-1487-3) | 90 tablet | 2021-12-28 | No | No | Historical |
| 71335-1487-4 | 71335148704 | 10 TABLET in 1 BOTTLE (71335-1487-4) | 10 tablet | 2021-12-28 | No | No | Historical |
| 71335-1487-5 | 71335148705 | 180 TABLET in 1 BOTTLE (71335-1487-5) | 180 tablet | 2025-09-23 | No | No | Historical |