FDA.reportPublic FDA data

NDC 65862-673-10 - Felodipine

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
65862-673
Requested NDC
65862-673-10
Package NDCs from labels
65862-673-90, 65862-673-01, 65862-673-99, 65862-673-10, 65862-673-78
Manufacturer
Aurobindo Pharma Limited
Effective date
2024-02-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Felodipine - Aurobindo Pharma LimitedAurobindo Pharma Limited2024-02-17Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-673-01Felodipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004
65862-673-10Felodipine10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE104
65862-673-78Felodipine10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE104
65862-673-90Felodipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904
65862-673-99Felodipine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-673FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 5 package rows20240218_dd39c559-5c5d-4d3b-9228-c44085e1699f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-673-01EA - Each65862-673ec9f8b53-40d3-4502-a96e-22a153dadf6f12014-01-04
65862-673-99EA - Each65862-67314433849-07e2-40e7-853c-40f49b9ff8dd12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
ALUMINUM SILICATEINACTIVE INGREDIENTT1FAD4SS2MFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]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 18 of 133 · 2,645 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
FelodipineFELODIPINETorrent Pharmaceuticals Limited60fb803e-ccf7-46f2-b506-e157ce440f872026-02-09Adverse reactionsExact identifier
rxcui: 402695
rxcui: 402698
rxcui: 402696
unii: OL961R6O2C
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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