Flecainide Acetate
- Product NDC
- 62135-661
- 11-digit product format
- 621350661
- Labeler code
- 62135
- Product ID
- 62135-661_25893d71-9846-59aa-e063-6294a90a3f48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flecainide Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA079164
- Marketing category
- ANDA
- Marketing start
- 2009-07-09
- Substance
- FLECAINIDE ACETATE
- Active strength
- 100 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 | 100 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 |
|---|
| 62135-661-60 | Flecainide Acetate | 60 in 1 BOTTLE, GLASS | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-661 | FLECAINIDE ACETATE TABLET [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241030_a604aee4-30d5-4007-9882-98137d0d867f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-661-60 | 62135066160 | 60 TABLET in 1 BOTTLE, GLASS (62135-661-60) | 60 tablet | 2023-06-21 | No | No | Historical |