Flecainide Acetate
- Product NDC
- 57237-063
- 11-digit product format
- 572370063
- Labeler code
- 57237
- Product ID
- 57237-063_c6b596c3-30c8-4bf6-89f6-03026358a3c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flecainide Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA202821
- Marketing category
- ANDA
- Marketing start
- 2015-07-08
- 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 |
|---|---|
| FLECAINIDE ACETATE | 50 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | M8U465Q1WQ |
| Rxcui | 886662, 886666, 886671 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 47936aaf-dd8f-a65f-335e-74a6c45bbd64 | Product name | 5 | 20231128 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-063-01 | Flecainide Acetate | 100 in 1 BOTTLE | TABLET | 100 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-063-01 | EA - Each | 57237-063 | cab874c2-b42b-49eb-87dc-43a47cbb79a7 | 1 | 2015-09-10 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLECAINIDE ACETATE | ACTIVE INGREDIENT | M8U465Q1WQ | FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC] | 1 | |
| FLECAINIDE | ACTIVE MOIETY | K94FTS1806 | FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC] | 1 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 886662 | flecainide acetate 50 MG Oral Tablet | PSN | 5d6a4772-663e-468d-a8e1-4085e1b32bf7 | 104 |
| 886662 | flecainide acetate 50 MG Oral Tablet | SCD | 5d6a4772-663e-468d-a8e1-4085e1b32bf7 | 104 |
| 886662 | flecainide acetate 50 MG Oral Tablet | PSN | 475a52a9-f18c-4a69-91f0-8f5e601f4336 | 7 |
| 886662 | flecainide acetate 50 MG Oral Tablet | SCD | 475a52a9-f18c-4a69-91f0-8f5e601f4336 | 7 |
| 886666 | flecainide acetate 100 MG Oral Tablet | PSN | e56335c1-5508-4136-bd2e-18385623e497 | 6 |
| 886671 | flecainide acetate 150 MG Oral Tablet | PSN | e56335c1-5508-4136-bd2e-18385623e497 | 6 |
| 886662 | flecainide acetate 50 MG Oral Tablet | PSN | e56335c1-5508-4136-bd2e-18385623e497 | 6 |
| 886666 | flecainide acetate 100 MG Oral Tablet | SCD | e56335c1-5508-4136-bd2e-18385623e497 | 6 |
| 886671 | flecainide acetate 150 MG Oral Tablet | SCD | e56335c1-5508-4136-bd2e-18385623e497 | 6 |
| 886662 | flecainide acetate 50 MG Oral Tablet | SCD | e56335c1-5508-4136-bd2e-18385623e497 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57237-063-01 | 57237006301 | 100 TABLET in 1 BOTTLE (57237-063-01) | 100 tablet | 2015-07-08 | 0000-00-00 | No | No | Current |