FDA.reportPublic FDA data

NDC 63629-7982-01 - 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
63629-7982
Requested NDC
63629-7982-01
Package NDCs from labels
63629-7982-4, 63629-7982-1, 63629-7982-2, 63629-7982-3, 63629-7982-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-03
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 Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7982-1Flecainide Acetate30 in 1 BOTTLETABLET305
63629-7982-2Flecainide Acetate60 in 1 BOTTLETABLET605
63629-7982-3Flecainide Acetate90 in 1 BOTTLETABLET905
63629-7982-4Flecainide Acetate180 in 1 BOTTLETABLET1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7982FLECAINIDE ACETATE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 4 package rows20240502_2013e6ef-9141-42c3-8ea8-285840ecdd15.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7982-3EA - Each63629-7982ef261638-6ef9-443a-ac72-f190f02759a812025-08-11

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack2028149f-6fc0-455c-bac5-729eeaa4aee52025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATE TABLETANI Pharmaceuticals, Inc.5a12889a-52ce-4dc4-9240-22d126f071ac2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackbf810a3b-1a71-4a05-bf54-d5a6caba444b2025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
unii: M8U465Q1WQ
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Flecainide AcetateFLECAINIDE ACETATEHikma Pharmaceuticals USA Inc.4f6b78d4-8ac8-464b-bb78-ee70cbc978982024-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions475a52a9-f18c-4a69-91f0-8f5e601f43362024-11-13Boxed warning, Adverse reactionsExact identifier
application number: ANDA202821
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEChartwell RX, LLCa604aee4-30d5-4007-9882-98137d0d867f2024-10-28Warnings, Adverse reactionsExact identifier
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEAmneal Pharmaceuticals LLCd462d58e-fc3c-4c92-a210-e135eb1f4b772024-10-25Warnings, Adverse reactionsExact identifier
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATE TABLETProficient Rx LPee590951-cce8-4a1e-b3bd-ae0b610ebda92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack6b73e32f-851b-4503-8296-e5db3a584b752024-05-24Boxed warning, Adverse reactionsExact identifier
application number: ANDA202821
rxcui: 886671
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack2013e6ef-9141-42c3-8ea8-285840ecdd152024-04-03Boxed warning, Adverse reactionsExact identifier
application number: ANDA202821
ndc (package): 63629-7982-1
ndc (package): 63629-7982-3
ndc (package): 63629-7982-4
ndc (package): 63629-7982-2
ndc (product): 63629-7982
ndc11 (package): 63629798201
rxcui: 886666
spl id: 1a02594a-dc61-44e8-939f-41786366f079
spl set id: 2013e6ef-9141-42c3-8ea8-285840ecdd15
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack5d6a4772-663e-468d-a8e1-4085e1b32bf72024-04-03Boxed warning, Adverse reactionsExact identifier
application number: ANDA202821
rxcui: 886662
unii: M8U465Q1WQ
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Flecainide AcetateFLECAINIDE ACETATEAurobindo Pharma Limited14e89448-3a18-42e3-8537-2589be1ef94e2024-01-09Boxed warning, Adverse reactionsExact identifier
application number: ANDA202821
rxcui: 886671
rxcui: 886666
rxcui: 886662
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATERising Pharma Holdings, Inc.e56335c1-5508-4136-bd2e-18385623e4972024-01-09Boxed warning, Adverse reactionsExact identifier
application number: ANDA202821
ndc (product): 57237-064
rxcui: 886671
rxcui: 886666
rxcui: 886662
spl id: c6b596c3-30c8-4bf6-89f6-03026358a3c6
spl set id: e56335c1-5508-4136-bd2e-18385623e497
unii: M8U465Q1WQ
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions179e3821-0342-4b84-96bb-3fcab213d74f2023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 886662
unii: M8U465Q1WQ

Reported adverse events (FAERS/openFDA)#

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