FDA.reportPublic FDA data

Rivastigmine Tartrate

Product NDC
65862-649
11-digit product format
658620649
Labeler code
65862
Product ID
65862-649_41507ad1-b7a7-40be-aa24-60a95b60f988
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204572
Marketing category
ANDA
Marketing start
2016-03-25
Substance
RIVASTIGMINE TARTRATE
Active strength
3 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 TARTRATE3 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
65862-649-05Rivastigmine Tartrate500 in 1 BOTTLECAPSULE5009
65862-649-10Rivastigmine Tartrate10 in 1 BLISTER PACKCAPSULE109
65862-649-60Rivastigmine Tartrate60 in 1 BOTTLECAPSULE609
65862-649-78Rivastigmine Tartrate10 in 1 CARTONCAPSULE109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-649RIVASTIGMINE TARTRATE CAPSULE [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 4 package rows20240620_c246a0e5-1e77-41ee-a7b3-384f21f2f2e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSNc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312835rivastigmine tartrate 3 MG Oral CapsulePSNc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314215rivastigmine tartrate 4.5 MG Oral CapsulePSNc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312836rivastigmine tartrate 6 MG Oral CapsulePSNc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314214rivastigmine 1.5 MG Oral CapsuleSCDc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312835rivastigmine 3 MG Oral CapsuleSCDc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314215rivastigmine 4.5 MG Oral CapsuleSCDc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312836rivastigmine 6 MG Oral CapsuleSCDc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSYc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSYc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSYc246a0e5-1e77-41ee-a7b3-384f21f2f2e09
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSYc246a0e5-1e77-41ee-a7b3-384f21f2f2e09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-649-0565862064905500 CAPSULE in 1 BOTTLE (65862-649-05) 500 capsule2016-03-250000-00-00NoNoCurrent
65862-649-106586206491010 in 1 BLISTER PACKHistorical
65862-649-39658620649393000 CAPSULE in 1 BAG (65862-649-39)3000 capsule25-MAR-16Current
65862-649-606586206496060 CAPSULE in 1 BOTTLE (65862-649-60) 60 capsule2016-03-250000-00-00NoNoCurrent
65862-649-786586206497810 BLISTER PACK in 1 CARTON (65862-649-78) / 10 CAPSULE in 1 BLISTER PACK (65862-649-10) 10 blister pack2016-03-250000-00-00NoNoCurrent