FDA.reportPublic FDA data

NDC 50268-321-11 - Flecainide Acetate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50268-321
Requested NDC
50268-321-11
Package NDCs from labels
50268-321-11, 50268-321-15
Manufacturer
AvPAK
Effective date
2026-01-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Flecainide Acetate - AvPAKAvPAK2026-01-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-321-11Flecainide Acetate1 in 1 BLISTER PACKTABLET19
50268-321-15Flecainide Acetate50 in 1 BOX, UNIT-DOSETABLET509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-321FLECAINIDE ACETATE TABLET [AVPAK]7Current NDC, Legacy NDC, 2 package rows20240110_f53e1a49-6185-6db4-c867-ffd1241a8cb7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-321-11EA - Each50268-32166be8525-f48a-4903-b522-784d6d74fc7412015-06-09
50268-321-15EA - Each50268-321831a91fe-df32-4104-89c4-5a89e2ba66a012015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLECAINIDE ACETATEACTIVE INGREDIENTM8U465Q1WQFLECAINIDE ACETATE TABLET [AVPAK]1
FLECAINIDEACTIVE MOIETYK94FTS1806FLECAINIDE ACETATE TABLET [AVPAK]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UFLECAINIDE ACETATE TABLET [AVPAK]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48FLECAINIDE ACETATE TABLET [AVPAK]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30FLECAINIDE ACETATE TABLET [AVPAK]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flecainide AcetateFLECAINIDE ACETATEAmneal Pharmaceuticals of New York LLCee9595d5-08a1-4529-9215-ddc3c7f929c42026-06-11Warnings, Adverse reactionsExact identifier
application number: ANDA075442
ndc (product): 53746-642
ndc (product): 53746-641
ndc (product): 53746-643
rxcui: 886671
rxcui: 886666
rxcui: 886662
spl id: e9e0eab5-efc5-4bac-8d46-0bce60b2fcc5
spl set id: ee9595d5-08a1-4529-9215-ddc3c7f929c4
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEEpic Pharma, LLC74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepacka30103c5-a261-49a5-a7b3-f43eb77e87b72026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886666
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEPD-Rx Pharmaceuticals, Inc.abcb261b-30ae-4eb1-baf0-e9667a2bd8cf2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886666
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEPD-Rx Pharmaceuticals, Inc.2b336028-1e13-4ef7-b75e-345bc9c06f9a2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEPD-Rx Pharmaceuticals, Inc.45d39dff-22d9-4c04-af26-0cffd41abaa82026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack8a900f29-85e1-464c-ae9e-44dc7cf11f462026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886666
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack5cfa10ba-dfe8-42ab-81b3-8cca657aba072026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackb821ec16-93ff-4569-9fbb-4f3842c58bec2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEUNICHEM PHARMACEUTICALS (USA), INC.5b33e96a-8336-46c4-aac7-4a6c0039cc802026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEAvPAKf53e1a49-6185-6db4-c867-ffd1241a8cb72026-01-11Warnings, Adverse reactionsExact identifier
application number: ANDA075442
ndc (package): 50268-321-15
ndc (package): 50268-320-15
ndc (package): 50268-322-15
ndc (package): 50268-320-11
ndc (package): 50268-322-11
ndc (package): 50268-321-11
ndc (product): 50268-321
ndc (product): 50268-322
ndc (product): 50268-320
ndc11 (package): 50268032111
rxcui: 886671
rxcui: 886666
rxcui: 886662
spl id: 48253893-9512-565b-e063-6294a90a8ad8
spl set id: f53e1a49-6185-6db4-c867-ffd1241a8cb7
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions166aa9e4-3402-4ebd-baa5-07a8da8aae562026-01-06Warnings, Adverse reactionsExact identifier
application number: ANDA075442
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions1a2a5e08-2697-4a00-94fe-de07148acbd92025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886666
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackbc304b04-9373-4e47-905d-6b3367ad3be72025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackd34fae51-3658-4456-b3ea-1217f0f522602025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackcf143926-439b-4005-be0e-1e049b44c0442025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886666
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackf0416c8c-faae-4e31-aa50-1fb7df10abf02025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack9929c166-8ba3-4159-a5f9-4618d5d227b02025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATE TABLETGolden State Medical Supply, Inc.74355cd2-b50e-0dc2-e053-2a91aa0aa1642025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack8dc86db1-2a09-4625-80eb-ff6ce9de2d7a2025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886666
unii: M8U465Q1WQ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.