Flecainide Acetate
- Product NDC
- 63304-795
- 11-digit product format
- 633040795
- Labeler code
- 63304
- Product ID
- 63304-795_f13a72ef-8d6e-42e8-985e-d31ec9c07525
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flecainide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ranbaxy Pharmaceuticals Inc.
- Application
- ANDA076421
- Marketing category
- ANDA
- Marketing start
- 2004-02-28
- Marketing end
- 0000-00-00
- Substance
- FLECAINIDE ACETATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 47936aaf-dd8f-a65f-335e-74a6c45bbd64 | Product name | 5 | 20231128 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63304-795-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5b4b-f424-e053-dadaa90a57ce | FLECAINIDE ACETATE TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63304-795-01 | Flecainide Acetate | 100 in 1 BOTTLE, UNIT-DOSE | TABLET | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63304-795-01 | EA - Each | 63304-795 | fb92ed0d-e574-4592-a51d-c6f5eec11622 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLECAINIDE ACETATE | ACTIVE INGREDIENT | M8U465Q1WQ | FLECAINIDE ACETATE (FLECAINIDE ) TABLET [RANBAXY PHARMACEUTICALS INC.] | 2 | |
| FLECAINIDE | ACTIVE MOIETY | K94FTS1806 | FLECAINIDE ACETATE (FLECAINIDE ) TABLET [RANBAXY PHARMACEUTICALS INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLECAINIDE ACETATE (FLECAINIDE ) TABLET [RANBAXY PHARMACEUTICALS INC.] | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLECAINIDE ACETATE (FLECAINIDE ) TABLET [RANBAXY PHARMACEUTICALS INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLECAINIDE ACETATE (FLECAINIDE ) TABLET [RANBAXY PHARMACEUTICALS INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLECAINIDE ACETATE (FLECAINIDE ) TABLET [RANBAXY PHARMACEUTICALS INC.] | 2 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLECAINIDE ACETATE (FLECAINIDE ) TABLET [RANBAXY PHARMACEUTICALS INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 886666 | flecainide acetate 100 MG Oral Tablet | PSN | fa68b35e-9f50-408b-9e70-e84cecf3fd6e | 2 |
| 886671 | flecainide acetate 150 MG Oral Tablet | PSN | fa68b35e-9f50-408b-9e70-e84cecf3fd6e | 2 |
| 886662 | flecainide acetate 50 MG Oral Tablet | PSN | fa68b35e-9f50-408b-9e70-e84cecf3fd6e | 2 |
| 886666 | flecainide acetate 100 MG Oral Tablet | SCD | fa68b35e-9f50-408b-9e70-e84cecf3fd6e | 2 |
| 886671 | flecainide acetate 150 MG Oral Tablet | SCD | fa68b35e-9f50-408b-9e70-e84cecf3fd6e | 2 |
| 886662 | flecainide acetate 50 MG Oral Tablet | SCD | fa68b35e-9f50-408b-9e70-e84cecf3fd6e | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 63304-795-01 | 63304079501 | 100 in 1 BOTTLE, UNIT-DOSE | Historical |