NDC 0054-0010

Flecainide Acetate

Flecainide Acetate

Flecainide Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Flecainide Acetate.

• Product ID: 0054-0010_fb4e03f5-aaef-472e-8109-7726f6362c22
• NDC: 0054-0010
• Product Type: Human Prescription Drug
• Proprietary Name: Flecainide Acetate
• Generic Name: Flecainide Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2003-01-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076278
• Labeler Name: West-Ward Pharmaceuticals Corp.
• Substance Name: FLECAINIDE ACETATE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Antiarrhythmic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0054-0010-20

100 BLISTER PACK in 1 CARTON (0054-0010-20) > 1 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2003-01-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0054-0010-21 [00054001021]

Flecainide Acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA076278
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-01-14

NDC 0054-0010-20 [00054001020]

Flecainide Acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA076278
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-01-14

NDC 0054-0010-25 [00054001025]

Flecainide Acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA076278
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-01-14

Drug Details

Active Ingredients

Ingredient	Strength
FLECAINIDE ACETATE	50 mg/1

OpenFDA Data

• SPL SET ID: 4f6b78d4-8ac8-464b-bb78-ee70cbc97898
• Manufacturer:
  • West-Ward Pharmaceuticals Corp.
• UNII:
  • M8U465Q1WQ
• RxNorm Concept Unique ID - RxCUI:
  • 886662
  • 886671
  • 886666
• UPC Code:
  • 0300540012212
  • 0300540011215

Pharmacological Class

• Antiarrhythmic [EPC]
• Antiarrhythmic [EPC]

NDC Crossover Matching brand name "Flecainide Acetate" or generic name "Flecainide Acetate"

NDC	Brand Name	Generic Name
0054-0010	Flecainide Acetate	flecainide acetate
0054-0011	Flecainide Acetate	flecainide acetate
0054-0012	Flecainide Acetate	flecainide acetate
0179-0201	Flecainide Acetate	flecainide acetate
0179-0231	Flecainide Acetate	Flecainide Acetate Tablet
42291-293	Flecainide Acetate	Flecainide Acetate
42291-294	Flecainide Acetate	Flecainide Acetate
42291-295	Flecainide Acetate	Flecainide Acetate
42806-817	Flecainide Acetate	flecainide acetate
42806-818	Flecainide Acetate	flecainide acetate
42806-819	Flecainide Acetate	flecainide acetate
43199-056	Flecainide acetate	Flecainide acetate
43199-057	Flecainide acetate	Flecainide acetate
43199-058	Flecainide acetate	Flecainide acetate
50090-1132	Flecainide Acetate	flecainide acetate
50090-1133	Flecainide Acetate	Flecainide Acetate
50090-2233	Flecainide Acetate	Flecainide Acetate
50090-2968	Flecainide Acetate	Flecainide Acetate
50090-5267	Flecainide Acetate	Flecainide Acetate
50090-5306	Flecainide Acetate	Flecainide Acetate
50090-6035	Flecainide Acetate	Flecainide Acetate
50268-320	Flecainide Acetate	Flecainide Acetate
50268-321	Flecainide Acetate	Flecainide Acetate
50268-322	Flecainide Acetate	Flecainide Acetate
51407-018	Flecainide Acetate	Flecainide Acetate Tablet
51407-019	Flecainide Acetate	Flecainide Acetate Tablet
51407-020	Flecainide Acetate	Flecainide Acetate Tablet
68151-1464	Flecainide Acetate	Flecainide Acetate
53746-641	Flecainide Acetate	Flecainide Acetate
53746-643	Flecainide Acetate	Flecainide Acetate
53746-642	Flecainide Acetate	Flecainide Acetate
57237-063	Flecainide Acetate	Flecainide Acetate
57237-065	Flecainide Acetate	Flecainide Acetate
57237-064	Flecainide Acetate	Flecainide Acetate
60687-225	Flecainide Acetate	Flecainide Acetate
62559-382	Flecainide Acetate	Flecainide Acetate
62559-380	Flecainide Acetate	Flecainide Acetate
62559-381	Flecainide Acetate	Flecainide Acetate
63304-795	Flecainide Acetate	Flecainide Acetate
63304-794	Flecainide Acetate	Flecainide Acetate
63304-796	Flecainide Acetate	Flecainide Acetate
65162-643	Flecainide Acetate	Flecainide Acetate
65162-641	Flecainide Acetate	Flecainide Acetate
65862-621	Flecainide Acetate	Flecainide Acetate
65162-642	Flecainide Acetate	Flecainide Acetate
65862-622	Flecainide Acetate	Flecainide Acetate
65862-623	Flecainide Acetate	Flecainide Acetate
63629-7979	Flecainide Acetate	Flecainide Acetate
63629-7982	Flecainide Acetate	Flecainide Acetate