Flecainide Acetate
- Product NDC
- 65862-621
- 11-digit product format
- 658620621
- Labeler code
- 65862
- Product ID
- 65862-621_c100187f-d40e-4ffe-aab7-068a9f3bd7b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flecainide Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202821
- Marketing category
- ANDA
- Marketing start
- 2017-11-03
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flecainide Acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLECAINIDE ACETATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M8U465Q1WQ |
| Rxcui | 886662, 886666, 886671 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-621-01 | Flecainide Acetate | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 65862-621-30 | Flecainide Acetate | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 65862-621-99 | Flecainide Acetate | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-621 | FLECAINIDE ACETATE TABLET [AUROBINDO PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240110_14e89448-3a18-42e3-8537-2589be1ef94e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-621-01 | 65862062101 | 100 TABLET in 1 BOTTLE (65862-621-01) | 100 tablet | 2017-11-03 | 0000-00-00 | No | No | Current |
| 65862-621-30 | 65862062130 | 30 TABLET in 1 BOTTLE (65862-621-30) | 30 tablet | 2017-11-03 | 0000-00-00 | No | No | Current |
| 65862-621-99 | 65862062199 | 1000 TABLET in 1 BOTTLE (65862-621-99) | 1000 tablet | 2017-11-03 | 0000-00-00 | No | No | Current |