Rivastigmine Tartrate

Product NDC
62756-148
11-digit product format
627560148
Labeler code
62756
Product ID
62756-148_a905f5ce-ae1b-4511-acd3-62883a3e3546
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077131
Marketing category
ANDA
Marketing start
2010-07-01
Substance
RIVASTIGMINE TARTRATE
Active strength
6 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rivastigmine Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVASTIGMINE TARTRATE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9IY2357JPE
Rxcui312835, 312836, 314214, 314215

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
62756-148-13Rivastigmine Tartrate500 in 1 BOTTLECAPSULE5008
62756-148-61Rivastigmine Tartrate1 in 1 BLISTER PACKCAPSULE18
62756-148-61Rivastigmine Tartrate100 in 1 BOX, UNIT-DOSECAPSULE1008
62756-148-86Rivastigmine Tartrate60 in 1 BOTTLECAPSULE608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-148-13EA - Each62756-148fb4c365f-d616-414a-81a0-e60b217e19b612012-07-24
62756-148-86EA - Each62756-148325927bd-b22c-470f-8cb1-8ea8b67b637312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIVASTIGMINE TARTRATEACTIVE INGREDIENT9IY2357JPERIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
RIVASTIGMINEACTIVE MOIETYPKI06M3IW0RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MRIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XRIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
GELATININACTIVE INGREDIENT2G86QN327LRIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TRIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SHELLACINACTIVE INGREDIENT46N107B71ORIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
RIVASTIGMINE TARTRATEACTIVE INGREDIENT9IY2357JPERIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
RIVASTIGMINEACTIVE MOIETYPKI06M3IW0RIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LRIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIVASTIGMINE TARTRATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-148RIVASTIGMINE TARTRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 4 package rows20190205_bac9ca81-db70-41aa-82af-6c5bb8496846.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSNbac9ca81-db70-41aa-82af-6c5bb84968468
312835rivastigmine tartrate 3 MG Oral CapsulePSNbac9ca81-db70-41aa-82af-6c5bb84968468
314215rivastigmine tartrate 4.5 MG Oral CapsulePSNbac9ca81-db70-41aa-82af-6c5bb84968468
312836rivastigmine tartrate 6 MG Oral CapsulePSNbac9ca81-db70-41aa-82af-6c5bb84968468
314214rivastigmine 1.5 MG Oral CapsuleSCDbac9ca81-db70-41aa-82af-6c5bb84968468
312835rivastigmine 3 MG Oral CapsuleSCDbac9ca81-db70-41aa-82af-6c5bb84968468
314215rivastigmine 4.5 MG Oral CapsuleSCDbac9ca81-db70-41aa-82af-6c5bb84968468
312836rivastigmine 6 MG Oral CapsuleSCDbac9ca81-db70-41aa-82af-6c5bb84968468
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSYbac9ca81-db70-41aa-82af-6c5bb84968468
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSYbac9ca81-db70-41aa-82af-6c5bb84968468
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSYbac9ca81-db70-41aa-82af-6c5bb84968468
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSYbac9ca81-db70-41aa-82af-6c5bb84968468

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-148-1362756014813500 CAPSULE in 1 BOTTLE (62756-148-13) 500 capsule2010-07-010000-00-00NoNoCurrent
62756-148-6162756014861100 BLISTER PACK in 1 BOX, UNIT-DOSE (62756-148-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2010-07-010000-00-00NoNoCurrent
62756-148-866275601488660 CAPSULE in 1 BOTTLE (62756-148-86) 60 capsule2010-07-010000-00-00NoNoCurrent