FDA.reportPublic FDA data

NDC 63629-7833-08 - Sildenafil

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
63629-7833
Requested NDC
63629-7833-08
Package NDCs from labels
63629-7833-1, 63629-7833-2, 63629-7833-3, 63629-7833-4, 63629-7833-5, 63629-7833-6, 63629-7833-7, 63629-7833-8, 63629-7833-08
Manufacturer
Bryant Ranch Prepack
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sildenafil - Bryant Ranch PrepackBryant Ranch Prepack2026-08-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7833-12024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-12024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-22024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-22024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-32024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-32024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-42024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-42024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-52024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-52024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-62024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-62024-05-14These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-12024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-12024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-22024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-22024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-32024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-32024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-42024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-42024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-52024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-52024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-62024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
63629-7833-62024-01-30These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7833-1Sildenafil30 in 1 BOTTLETABLET, FILM COATED309
63629-7833-2Sildenafil10 in 1 BOTTLETABLET, FILM COATED109
63629-7833-3Sildenafil15 in 1 BOTTLETABLET, FILM COATED159
63629-7833-4Sildenafil90 in 1 BOTTLETABLET, FILM COATED909
63629-7833-5Sildenafil60 in 1 BOTTLETABLET, FILM COATED609
63629-7833-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED209
63629-7833-7Sildenafil7 in 1 BOTTLETABLET, FILM COATED79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7833SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 7 package rows20240516_dfe4f616-b5de-458c-a97b-ab860e32320c.zip

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 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILPreferred Pharmaceuticals, Inc.174ef537-e3e6-42bd-a478-47b930ddc7612026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 314229
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILPreferred Pharmaceuticals Inc.878b4c44-cddc-42cb-b9b5-911451ad15302026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 314229
unii: BW9B0ZE037
SildenafilSILDENAFILPreferred Pharmaceuticals Inc.d887377e-90c5-44dc-8455-b23a6755b36f2026-08-28Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILBryant Ranch Prepack96ae6733-cef9-46cf-bf4e-5368201943bd2026-08-19Warnings, Adverse reactionsExact identifier
application number: ANDA202023
rxcui: 314229
unii: BW9B0ZE037
SILDENAFILSILDENAFILCardinal Health 107, LLCc5ac2265-393a-4fbe-b974-1dd0b9243ec82026-08-12Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.1b1ab00d-de9c-4614-e063-6394a90afcde2026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 312950
unii: BW9B0ZE037
SildenafilSILDENAFILBryant Ranch Prepackdfe4f616-b5de-458c-a97b-ab860e32320c2026-08-11Warnings, Adverse reactionsExact identifier
application number: ANDA202023
ndc (package): 63629-7833-7
ndc (package): 63629-7833-6
ndc (package): 63629-7833-3
ndc (package): 63629-7833-2
ndc (package): 63629-7833-8
ndc (package): 63629-7833-4
ndc (package): 63629-7833-1
ndc (package): 63629-7833-5
ndc (product): 63629-7833
ndc11 (package): 63629783308
rxcui: 312950
spl id: fd77efe1-6233-489b-838c-aa3c9cf9d3f5
spl set id: dfe4f616-b5de-458c-a97b-ab860e32320c
unii: BW9B0ZE037
SildenafilSILDENAFILA-S Medication Solutionsdc38f412-dca7-4b54-b14c-314e7a251ee62026-08-10Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILBryant Ranch Prepacka636d3c7-af25-4148-8b4e-6f44deba700b2026-08-06Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILJubilant Cadista Pharmaceuticals Inc.1ed2420b-478a-ca9c-0330-85c845acdd322026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 314229
rxcui: 312950
rxcui: 314228
unii: BW9B0ZE037
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 314228
unii: BW9B0ZE037
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.f1122baa-8dee-43fc-bd3d-501a55b696b32026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 314229
unii: BW9B0ZE037
SildenafilSILDENAFIL CITRATEYaral Pharma Inc.a17a970e-25a2-4807-9644-74e6d2bd23832026-07-17Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILAmneal Pharmaceuticals LLC187de471-3e79-44ed-b560-0f8b2d549f742026-07-16Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILREMEDYREPACK INC.99bc66a4-05d1-4372-a25a-1153d7af580e2026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 312950
unii: BW9B0ZE037
SildenafilSILDENAFILREMEDYREPACK INC.e4f41e9e-d508-4f91-8677-8a19b07139de2026-07-09Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
VybriqueSILDENAFIL CITRATEIBSA Pharma Inc.9213fec1-e0c0-4ef7-9718-d97922a3f4d82026-07-08Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILPD-Rx Pharmaceuticals, Inc.e1af7b6a-378e-4337-858f-85a926eec1022026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 314229
unii: BW9B0ZE037
SildenafilSILDENAFILPD-Rx Pharmaceuticals, Inc.4e3034af-bee5-4df4-8beb-fbd2b510ad732026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 312950
unii: BW9B0ZE037
SildenafilSILDENAFILAmneal Pharmaceuticals NY LLCa1c3a2a2-8cf5-41c3-9c86-54290570d9162026-07-06Warnings, Adverse reactionsExact identifier
application number: ANDA202023
ndc (product): 60219-1752
rxcui: 314229
rxcui: 312950
rxcui: 314228
spl id: 64d4569d-26f0-4120-bc1e-c8dc47dcb387
spl set id: a1c3a2a2-8cf5-41c3-9c86-54290570d916
unii: BW9B0ZE037

Reported adverse events (FAERS/openFDA)#

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