FDA.reportPublic FDA data

NDC 0078-0502-61 - Exelon

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
0078-0502
Requested NDC
0078-0502-61
Package NDCs from labels
0078-0502-61, 0078-0502-15
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2024-05-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Exelon - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2024-05-08HUMAN PRESCRIPTION DRUG LABEL
Exelon - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-02-22HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0502-15Exelon30 in 1 CARTONPATCH, EXTENDED RELEASE3030
0078-0502-61Exelon24 h in 1 PATCHPATCH, EXTENDED RELEASE2430

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0502EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]29Current NDC, Legacy NDC, 2 package rows20240517_07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0502-15EA - Each0078-0502976ff0bf-0340-4a4c-9943-9129cb1dd22e12012-07-24
0078-0502-61EA - Each0078-0502c313127f-8dd4-42eb-9d43-9c0e944ba34512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIVASTIGMINEACTIVE INGREDIENTPKI06M3IW0EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
RIVASTIGMINEACTIVE MOIETYPKI06M3IW0EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
RIVASTIGMINEACTIVE INGREDIENTPKI06M3IW0EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
RIVASTIGMINEACTIVE MOIETYPKI06M3IW0EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack1ebeb8ec-5348-4bb1-ab3d-8346903510942024-12-24Warnings, Adverse reactionsExact identifier
rxcui: 725023
unii: PKI06M3IW0
RivastigmineRIVASTIGMINEMylan Pharmaceuticals Inc.4ab335d1-19ee-4cd9-9776-8086645d19e42024-09-21Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack82630f84-fb47-47ab-8ee2-1720a486de022024-08-19Warnings, Adverse reactionsExact identifier
rxcui: 725021
unii: PKI06M3IW0
RivastigmineRIVASTIGMINEAmneal Pharmaceuticals LLC8b671fc9-8cb0-4406-a9ee-7c95086d62002024-07-02Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepackc569f760-f311-42ba-909c-a36319622b352024-05-30Warnings, Adverse reactionsExact identifier
rxcui: 725023
unii: PKI06M3IW0
RivastigmineRIVASTIGMINEZydus Pharmaceuticals USA Inc.64dad603-2389-456b-8c18-d1d40b7e74192024-05-27Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
RivastigmineRIVASTIGMINESandoz Inc92a58ebb-748d-49f4-bf11-ecbcf54241522024-05-08Warnings, Adverse reactionsExact identifier
application number: NDA022083
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
ExelonRIVASTIGMINENovartis Pharmaceuticals Corporation07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e02024-05-08Warnings, Adverse reactionsExact identifier
application number: NDA022083
ndc (package): 0078-0503-15
ndc (package): 0078-0502-61
ndc (package): 0078-0501-15
ndc (package): 0078-0503-61
ndc (package): 0078-0501-61
ndc (package): 0078-0502-15
ndc (product): 0078-0501
ndc (product): 0078-0502
ndc (product): 0078-0503
ndc11 (package): 00078050261
rxcui: 725021
rxcui: 1308571
rxcui: 751302
rxcui: 725105
rxcui: 1308569
rxcui: 725023
spl id: 9b5555ca-d9a2-4f50-8037-abbf702d0a27
spl set id: 07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0
unii: PKI06M3IW0
ExelonRIVASTIGMINESandoz Incb6ed6d15-116d-4596-92ce-3414574d7ba02024-05-08Warnings, Adverse reactionsExact identifier
application number: NDA022083
rxcui: 725021
rxcui: 1308571
rxcui: 751302
rxcui: 725105
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.34b2924f-d220-4344-8cdd-e7dda54061c22024-02-02WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.3d5fbe3a-a95b-4688-a96e-b34e6e1e868a2024-02-01WarningsExact identifier
unii: H4N855PNZ1
Pain FormulaSALIX ALBA, ASCORBICUM ACIDUM, VITAMIN A, VITAMIN E, ACETYLSALICYLICUM ACIDUMNutritional Specialties, Inc.0cc0d205-83c2-4205-a93c-6a8ba55956d42023-11-20WarningsExact identifier
unii: H4N855PNZ1
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: H4N855PNZ1
Telomere - DNACA98, CAROTENOID, DNA, GLUTATHIONE, OMEGA 3, PITUITARUM, RNA, VITAMIN B COMPLEX, VITAMIN C, VITAMIN D3, VITAMIN EProBLENb093dfba-ed48-47a2-b4ce-f706221935a12022-11-30WarningsExact identifier
unii: H4N855PNZ1
Immune SupportARSENICUM ALBUM, RUMEX, SQUILLA MARITIMA, BRYONIA ALBA, KALI CARBONICUM, GLUTATHIONE, VITAMIN C, VITAMIN C, ZINC PICOLINATE, VITAMIN B, VITAMIN E, BETA GLUCAN, CURCUMIN, GRAPEFRUIT SEED, OREGANO LEAF, GARLIC BULB, OLIVE LEAF, APPLE CIDER VINEGAR, ASTRAGALUS ROOT, MAITAKE MUSHROOM, CATS CLAW BARKProBLENe6f26cf4-dc3d-4d31-aa3e-145167b6ba2b2022-11-30WarningsExact identifier
unii: H4N855PNZ1
ANTI AGE SKINALPHA-TOCOPHEROL - ASCOPHYLLUM NODOSUM - BOTRYOGLOSSUM PLATYCARPUM - FUCUS SERRATUS - FUCUS VESICULOSUS - ISOLEUCINE - LEUCINE - RETINOL - SELENIUM - SUS SCROFA CAPILLARY TISSUE - SUS SCROFA COLLAGEN - SUS SCROFA PLACENTA - SUS SCROFA SKIN - UBIDECARENONE - ULVA LACTUCA EXTRACT - LAMINARIA DIGITATAGuna spaf0c53be7-01ac-40ed-b3cd-8911ba7043462018-12-21WarningsExact identifier
unii: H4N855PNZ1
7cccdc96-0f15-4755-9d18-9d74f55a815c29481887-34eb-460a-bd7f-b8755473065a2010-02-22Warnings, Adverse reactionsExact identifier
spl id: 7cccdc96-0f15-4755-9d18-9d74f55a815c
spl set id: 29481887-34eb-460a-bd7f-b8755473065a

Reported adverse events (FAERS/openFDA)#

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