FDA.reportPublic FDA data

NDC 0781-7313-58 - Rivastigmine

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
0781-7313
Requested NDC
0781-7313-58
Package NDCs from labels
0781-7313-58, 0781-7313-31
Manufacturer
Sandoz Inc
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
Rivastigmine - Sandoz IncSandoz Inc2024-05-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-7313-31Rivastigmine30 in 1 CARTONPATCH, EXTENDED RELEASE305
0781-7313-58Rivastigmine24 h in 1 PATCHPATCH, EXTENDED RELEASE245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7313RIVASTIGMINE PATCH, EXTENDED RELEASE [SANDOZ INC]5Current NDC, Legacy NDC, 2 package rows20240823_92a58ebb-748d-49f4-bf11-ecbcf5424152.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7313-31EA - Each0781-73134f6ac82c-c6c8-46cb-80b8-615b5e79231512015-10-02
0781-7313-58EA - Each0781-731399277b1d-f7d6-472c-8860-2602bdaab76312016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIVASTIGMINEACTIVE INGREDIENTPKI06M3IW0RIVASTIGMINE PATCH, EXTENDED RELEASE [SANDOZ INC]1
RIVASTIGMINEACTIVE MOIETYPKI06M3IW0RIVASTIGMINE PATCH, EXTENDED RELEASE [SANDOZ INC]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1RIVASTIGMINE PATCH, EXTENDED RELEASE [SANDOZ INC]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 2 of 2 · 37 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
ndc (package): 0781-7313-31
ndc (package): 0781-7304-31
ndc (package): 0781-7309-58
ndc (package): 0781-7304-58
ndc (package): 0781-7309-31
ndc (package): 0781-7313-58
ndc (product): 0781-7313
ndc (product): 0781-7304
ndc (product): 0781-7309
ndc11 (package): 00781731358
rxcui: 725021
rxcui: 1308569
rxcui: 725023
spl id: 3a8271f5-aade-457e-8016-ef0f73c38f78
spl set id: 92a58ebb-748d-49f4-bf11-ecbcf5424152
unii: PKI06M3IW0
ExelonRIVASTIGMINENovartis Pharmaceuticals Corporation07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e02024-05-08Warnings, Adverse reactionsExact identifier
application number: NDA022083
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
ExelonRIVASTIGMINESandoz Incb6ed6d15-116d-4596-92ce-3414574d7ba02024-05-08Warnings, Adverse reactionsExact identifier
application number: NDA022083
rxcui: 725021
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

Reported adverse events (FAERS/openFDA)#

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