FDA.reportPublic FDA data

Exelon

Product NDC
21695-357
11-digit product format
216950357
Labeler code
21695
Product ID
21695-357_5d7c4d41-2df4-42d4-9a3d-0a567519bf2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rivastigmine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Rebel Distributors Corp
Application
NDA022083
Marketing category
NDA
Marketing start
2009-10-07
Marketing end
0000-00-00
Substance
RIVASTIGMINE
Active strength
5 mg/24[USP'U]
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-357-302019-09-24C16284748780-1934fe258-4d2b-48b1-e053-8cdaa90a720aExelon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-357-30Exelon30 in 1 CARTONPATCH, EXTENDED RELEASE301
21695-357-30Exelon24 [USP'U] in 1 PATCHPATCH, EXTENDED RELEASE241

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-357-30EA - Each21695-3577b6ccbd3-368d-4b87-9233-63bf08d2f9cb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
21695-357EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110103_5d7c4d41-2df4-42d4-9a3d-0a567519bf2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
21695-357-302169503573030 in 1 CARTONHistorical