FDA.reportPublic FDA data

Rivastigmine Tartrate

Product NDC
72241-013
11-digit product format
722410013
Labeler code
72241
Product ID
72241-013_27f32649-68c4-4f16-abaf-35cba6ac6b75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA203844
Marketing category
ANDA
Marketing start
2021-10-05
Substance
RIVASTIGMINE TARTRATE
Active strength
4.5 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 TARTRATE4.5 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
72241-013-03Rivastigmine Tartrate60 in 1 BOTTLECAPSULE602
72241-013-10Rivastigmine Tartrate500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-013-03EA - Each72241-0136bfe698e-0cf5-4567-a73a-1203c1d8e63612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-013RIVASTIGMINE TARTRATE CAPSULE [MODAVAR PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20221230_209f3b02-0acf-46e9-b355-91c918a20eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSN209f3b02-0acf-46e9-b355-91c918a20eb32
312835rivastigmine tartrate 3 MG Oral CapsulePSN209f3b02-0acf-46e9-b355-91c918a20eb32
314215rivastigmine tartrate 4.5 MG Oral CapsulePSN209f3b02-0acf-46e9-b355-91c918a20eb32
312836rivastigmine tartrate 6 MG Oral CapsulePSN209f3b02-0acf-46e9-b355-91c918a20eb32
314214rivastigmine 1.5 MG Oral CapsuleSCD209f3b02-0acf-46e9-b355-91c918a20eb32
312835rivastigmine 3 MG Oral CapsuleSCD209f3b02-0acf-46e9-b355-91c918a20eb32
314215rivastigmine 4.5 MG Oral CapsuleSCD209f3b02-0acf-46e9-b355-91c918a20eb32
312836rivastigmine 6 MG Oral CapsuleSCD209f3b02-0acf-46e9-b355-91c918a20eb32
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSY209f3b02-0acf-46e9-b355-91c918a20eb32
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSY209f3b02-0acf-46e9-b355-91c918a20eb32
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSY209f3b02-0acf-46e9-b355-91c918a20eb32
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSY209f3b02-0acf-46e9-b355-91c918a20eb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-013-037224100130360 CAPSULE in 1 BOTTLE (72241-013-03) 60 capsule2021-10-050000-00-00NoNoCurrent
72241-013-1072241001310500 CAPSULE in 1 BOTTLE (72241-013-10) 500 capsule2021-10-050000-00-00NoNoCurrent