FDA.reportPublic FDA data

Rivastigmine Tartrate

Product NDC
68151-4134
11-digit product format
681514134
Labeler code
68151
Product ID
68151-4134_3fc6b4c1-eb67-4c34-8feb-d1563e689592
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA077131
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
RIVASTIGMINE TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-4134-82020-01-31C16284748780-19d75b9d0-fcbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use rivastigmine tartrate capsules safely and effectively. See full prescribing information for rivastigmine tartrate capsules. RIVASTIGMINE tartrate capsules, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4134-8Rivastigmine Tartrate1 in 1 PACKAGECAPSULE14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIVASTIGMINE TARTRATEACTIVE INGREDIENT9IY2357JPERIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
RIVASTIGMINEACTIVE MOIETYPKI06M3IW0RIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
GELATININACTIVE INGREDIENT2G86QN327LRIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4134RIVASTIGMINE TARTRATE CAPSULE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20160806_6bddaf00-fb85-49e7-9aed-bc5efdfc4311.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSN6bddaf00-fb85-49e7-9aed-bc5efdfc43114
314214rivastigmine 1.5 MG Oral CapsuleSCD6bddaf00-fb85-49e7-9aed-bc5efdfc43114
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSY6bddaf00-fb85-49e7-9aed-bc5efdfc43114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4134-8681514134081 in 1 PACKAGEHistorical