FDA.reportPublic FDA data

NDC 63629-8288-01 - Tadalafil

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
63629-8288
Requested NDC
63629-8288-01
Package NDCs from labels
63629-8288-1, 63629-8288-2, 63629-8288-3, 63629-8288-4, 63629-8288-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tadalafil - Bryant Ranch PrepackBryant Ranch Prepack2024-08-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8288-1Tadalafil30 in 1 BOTTLETABLET30108
63629-8288-2Tadalafil90 in 1 BOTTLETABLET90108
63629-8288-3Tadalafil15 in 1 BOTTLETABLET15108
63629-8288-4Tadalafil60 in 1 BOTTLETABLET60108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8288TADALAFIL TABLET [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 4 package rows20240809_185a3284-3a4f-44d3-9278-98581d33f95b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8288-2EA - Each63629-8288382bfc8d-9544-4b8a-a3fe-eca18f748c6812024-04-05

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 85 of 113 · 2,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: LMI26O6933
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: LMI26O6933
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLCf2e8821e-04c9-4812-8c9e-39340775cc6e2024-09-12Warnings, Adverse reactionsExact identifier
rxcui: 484814
unii: 742SXX0ICT
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
unii: 15FIX9V2JP
TadalafilTADALAFILAlembic Pharmaceuticals Limited741102c1-8809-44d4-9098-3dc8c06047642024-09-05Warnings, Adverse reactionsExact identifier
rxcui: 402019
rxcui: 403957
rxcui: 757707
rxcui: 484814
unii: 742SXX0ICT
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
unii: 15FIX9V2JP
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
unii: 15FIX9V2JP
Freaks of Nature Peak Performance SPF50FREAKS OF NATURE PEAK PERFORMANCE SPF50Milbar Laboratories20b18cea-95e9-3527-e063-6294a90a4db42024-08-30WarningsExact identifier
unii: 15FIX9V2JP
TADALAFILTADALAFILSolco Healthcare US, LLC9489b635-385e-4a05-be02-df39fcafebe32024-08-27Warnings, Adverse reactionsExact identifier
unii: 742SXX0ICT
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDermio Dermatology LLC204973ce-dba4-8235-e063-6394a90a015c2024-08-22WarningsExact identifier
unii: 15FIX9V2JP
TadalafilTADALAFILBryant Ranch Prepack85ed0cbc-df84-44df-a9eb-f9587dbc21df2024-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA209654
rxcui: 402019
unii: 742SXX0ICT
MACKENZIES OCEAN SAFE SUNSCREENTITANIUM DIOXIDENaturally Uncommon, LLC1fd0a790-c66c-216f-e063-6294a90ae9712024-08-16WarningsExact identifier
unii: 15FIX9V2JP
tadalafilTADALAFILBryant Ranch Prepackff3c7dd3-2dcc-498c-a121-1e2aa62c7a972024-08-16Warnings, Adverse reactionsExact identifier
rxcui: 403957
unii: 742SXX0ICT
TadalafilTADALAFILZydus Lifesciences Limited6c1c3a1f-80a4-417c-8830-5edbb9a0710f2024-08-12Exact identifier
rxcui: 402019
rxcui: 403957
rxcui: 757707
rxcui: 484814
unii: 742SXX0ICT
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
unii: 15FIX9V2JP
TadalafilTADALAFILBryant Ranch Prepack185a3284-3a4f-44d3-9278-98581d33f95b2024-08-08Warnings, Adverse reactionsExact identifier
application number: ANDA209654
ndc (package): 63629-8288-2
ndc (package): 63629-8288-3
ndc (package): 63629-8288-4
ndc (package): 63629-8288-1
ndc (product): 63629-8288
ndc11 (package): 63629828801
rxcui: 403957
spl id: 08531412-01c1-4053-93b6-83f785a873cd
spl set id: 185a3284-3a4f-44d3-9278-98581d33f95b
unii: 742SXX0ICT
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb737146d-fb50-4ed6-ab5e-6aff3393992a2024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54b07420-6a30-4481-99f5-a7d6a4df898c2024-08-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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