FDA.reportPublic FDA data

NDC 71335-2995-01 - 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
71335-2995
Requested NDC
71335-2995-01
Package NDCs from labels
71335-2995-1, 71335-2995-2, 71335-2995-3, 71335-2995-4, 71335-2995-5, 71335-2995-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-02-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Flecainide Acetate - Bryant Ranch PrepackBryant Ranch Prepack2026-02-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2995-1Flecainide Acetate30 in 1 BOTTLETABLET301
71335-2995-2Flecainide Acetate60 in 1 BOTTLETABLET601
71335-2995-3Flecainide Acetate90 in 1 BOTTLETABLET901
71335-2995-4Flecainide Acetate10 in 1 BOTTLETABLET101
71335-2995-5Flecainide Acetate180 in 1 BOTTLETABLET1801

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 3 · 41 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
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEEpic Pharma, LLC74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215599
ndc (product): 42806-817
rxcui: 886671
rxcui: 886666
rxcui: 886662
spl id: 52eef22b-3545-b398-e063-6394a90aec29
spl set id: 74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepacka30103c5-a261-49a5-a7b3-f43eb77e87b72026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886666
unii: M8U465Q1WQ
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
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
application number: ANDA215599
rxcui: 886666
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack5cfa10ba-dfe8-42ab-81b3-8cca657aba072026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215599
ndc (package): 71335-2995-4
ndc (package): 71335-2995-5
ndc (package): 71335-2995-2
ndc (package): 71335-2995-3
ndc (package): 71335-2995-1
ndc (product): 71335-2995
ndc11 (package): 71335299501
rxcui: 886662
spl id: 7f3745b5-2c12-438a-bbdb-32e1803b73f3
spl set id: 5cfa10ba-dfe8-42ab-81b3-8cca657aba07
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackb821ec16-93ff-4569-9fbb-4f3842c58bec2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215599
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
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Flecainide AcetateFLECAINIDE ACETATEAvPAKf53e1a49-6185-6db4-c867-ffd1241a8cb72026-01-11Warnings, Adverse reactionsExact identifier
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions166aa9e4-3402-4ebd-baa5-07a8da8aae562026-01-06Warnings, Adverse reactionsExact identifier
rxcui: 886662
unii: M8U465Q1WQ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
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

Reported adverse events (FAERS/openFDA)#

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