FDA.reportPublic FDA data

Exelon

Product NDC
0078-0501
11-digit product format
000780501
Labeler code
0078
Product ID
0078-0501_9b5555ca-d9a2-4f50-8037-abbf702d0a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rivastigmine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA022083
Marketing category
NDA
Marketing start
2007-07-06
Marketing end
2026-12-31
Substance
RIVASTIGMINE
Active strength
4.6 mg/24h
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Exelon

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVASTIGMINE4.6 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPKI06M3IW0
Rxcui725021, 725023, 725105, 751302, 1308569, 1308571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f5a24cc0-a293-4838-b663-7e454a66c2c3Product name520200513
64bcf1db-afe4-78b0-8e9c-f7cb25e1b791Product name620171121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0501-15Exelon30 in 1 CARTONPATCH, EXTENDED RELEASE3030
0078-0501-61Exelon24 h in 1 PATCHPATCH, EXTENDED RELEASE2430

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0501-15EA - Each0078-05016b8db6cb-4590-4837-a158-c433d5427eee12012-07-24
0078-0501-61EA - Each0078-0501ab183bcd-6a26-4a0d-abee-8013770573fa12012-07-24

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
RIVASTIGMINEACTIVE INGREDIENTPKI06M3IW0EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
RIVASTIGMINEACTIVE MOIETYPKI06M3IW0EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0501EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]29Current NDC, Legacy NDC, 2 package rows20240517_07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1308571EXELON PATCH 13.3 MG/Day 24HR Transdermal SystemPSN07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
751302EXELON PATCH 4.6 MG/DAY 24HR Transdermal SystemPSN07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725105EXELON PATCH 9.5 MG/Day 24HR Transdermal SystemPSN07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemPSN07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSN07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemPSN07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
75130224 HR rivastigmine 0.192 MG/HR Transdermal System [Exelon]SBD07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
72510524 HR rivastigmine 0.396 MG/HR Transdermal System [Exelon]SBD07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
130857124 HR rivastigmine 0.554 MG/HR Transdermal System [Exelon]SBD07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCD07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
72502324 HR rivastigmine 0.396 MG/HR Transdermal SystemSCD07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
130856924 HR rivastigmine 0.554 MG/HR Transdermal SystemSCD07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
75130224 HR Exelon 0.192 MG/HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
72510524 HR Exelon 0.396 MG/HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
130857124 HR Exelon 0.554 MG/HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
751302Exelon 0.192 MG/HR 24HR Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725105Exelon 0.396 MG/HR 24 HR Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
1308571Exelon 13.3 MG per 24HR 1 Day Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
751302Exelon 4.6 MG per 24HR 1 Day Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725105Exelon 9.5 MG/Day 24 HR Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
1308571EXELON PATCH 13.3 MG/Day 24HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
751302EXELON PATCH 4.6 MG/DAY 24HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725105EXELON PATCH 9.5 MG/Day 24HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725023rivastigmine 0.396 MG/HR 24 HR Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
1308569rivastigmine 13.3 MG/Day 24HR Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725023rivastigmine 9.5 MG/Day 24 HR Transdermal PatchSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemSY07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e030
751302EXELON PATCH 4.6 MG/DAY 24HR Transdermal SystemPSN29481887-34eb-460a-bd7f-b8755473065a2
725105EXELON PATCH 9.5 MG/Day 24HR Transdermal SystemPSN29481887-34eb-460a-bd7f-b8755473065a2
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSN29481887-34eb-460a-bd7f-b8755473065a2
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemPSN29481887-34eb-460a-bd7f-b8755473065a2
75130224 HR rivastigmine 0.192 MG/HR Transdermal System [Exelon]SBD29481887-34eb-460a-bd7f-b8755473065a2
72510524 HR rivastigmine 0.396 MG/HR Transdermal System [Exelon]SBD29481887-34eb-460a-bd7f-b8755473065a2
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCD29481887-34eb-460a-bd7f-b8755473065a2
72502324 HR rivastigmine 0.396 MG/HR Transdermal SystemSCD29481887-34eb-460a-bd7f-b8755473065a2
75130224 HR Exelon 0.192 MG/HR Transdermal SystemSY29481887-34eb-460a-bd7f-b8755473065a2
72510524 HR Exelon 0.396 MG/HR Transdermal SystemSY29481887-34eb-460a-bd7f-b8755473065a2
751302Exelon 0.192 MG/HR 24HR Transdermal PatchSY29481887-34eb-460a-bd7f-b8755473065a2
725105Exelon 0.396 MG/HR 24 HR Transdermal PatchSY29481887-34eb-460a-bd7f-b8755473065a2
751302Exelon 4.6 MG per 24HR 1 Day Transdermal PatchSY29481887-34eb-460a-bd7f-b8755473065a2
725105Exelon 9.5 MG/Day 24 HR Transdermal PatchSY29481887-34eb-460a-bd7f-b8755473065a2
751302EXELON PATCH 4.6 MG/DAY 24HR Transdermal SystemSY29481887-34eb-460a-bd7f-b8755473065a2
725105EXELON PATCH 9.5 MG/Day 24HR Transdermal SystemSY29481887-34eb-460a-bd7f-b8755473065a2
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSY29481887-34eb-460a-bd7f-b8755473065a2
725023rivastigmine 0.396 MG/HR 24 HR Transdermal PatchSY29481887-34eb-460a-bd7f-b8755473065a2
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSY29481887-34eb-460a-bd7f-b8755473065a2
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSY29481887-34eb-460a-bd7f-b8755473065a2
725023rivastigmine 9.5 MG/Day 24 HR Transdermal PatchSY29481887-34eb-460a-bd7f-b8755473065a2
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemSY29481887-34eb-460a-bd7f-b8755473065a2
751302EXELON PATCH 4.6 MG/DAY 24HR Transdermal SystemPSN5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSN5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
75130224 HR rivastigmine 0.192 MG/HR Transdermal System [Exelon]SBD5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCD5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
75130224 HR Exelon 0.192 MG/HR Transdermal SystemSY5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
751302Exelon 0.192 MG/HR 24HR Transdermal PatchSY5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
751302Exelon 4.6 MG per 24HR 1 Day Transdermal PatchSY5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
751302EXELON PATCH 4.6 MG/DAY 24HR Transdermal SystemSY5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSY5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSY5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSY5d7c4d41-2df4-42d4-9a3d-0a567519bf2d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0501-150007805011530 PATCH in 1 CARTON (0078-0501-15) / 24 h in 1 PATCH (0078-0501-61) 30 patch2007-07-062026-12-31NoNoCurrent
0078-0501-610007805016124 h in 1 PATCH24 hHistorical