FDA.reportPublic FDA data

Rivastigmine Tartrate

Product NDC
62332-064
11-digit product format
623320064
Labeler code
62332
Product ID
62332-064_0044f1d7-613c-4611-8481-13032c8cb390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA091689
Marketing category
ANDA
Marketing start
2022-06-12
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
62332-064-10Rivastigmine Tartrate100 in 1 BOX, UNIT-DOSECAPSULE1001
62332-064-10Rivastigmine Tartrate10 in 1 BLISTER PACKCAPSULE101
62332-064-30Rivastigmine Tartrate30 in 1 BOTTLECAPSULE301
62332-064-60Rivastigmine Tartrate60 in 1 BOTTLECAPSULE601
62332-064-71Rivastigmine Tartrate500 in 1 BOTTLECAPSULE5001
62332-064-91Rivastigmine Tartrate1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-064-60EA - Each62332-064117eef1c-67f4-4fa9-bc0b-5771dbed798b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-064RIVASTIGMINE TARTRATE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 6 package rows20220612_0044f1d7-613c-4611-8481-13032c8cb390.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSN0044f1d7-613c-4611-8481-13032c8cb3901
312835rivastigmine tartrate 3 MG Oral CapsulePSN0044f1d7-613c-4611-8481-13032c8cb3901
314215rivastigmine tartrate 4.5 MG Oral CapsulePSN0044f1d7-613c-4611-8481-13032c8cb3901
312836rivastigmine tartrate 6 MG Oral CapsulePSN0044f1d7-613c-4611-8481-13032c8cb3901
314214rivastigmine 1.5 MG Oral CapsuleSCD0044f1d7-613c-4611-8481-13032c8cb3901
312835rivastigmine 3 MG Oral CapsuleSCD0044f1d7-613c-4611-8481-13032c8cb3901
314215rivastigmine 4.5 MG Oral CapsuleSCD0044f1d7-613c-4611-8481-13032c8cb3901
312836rivastigmine 6 MG Oral CapsuleSCD0044f1d7-613c-4611-8481-13032c8cb3901
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSY0044f1d7-613c-4611-8481-13032c8cb3901
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSY0044f1d7-613c-4611-8481-13032c8cb3901
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSY0044f1d7-613c-4611-8481-13032c8cb3901
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSY0044f1d7-613c-4611-8481-13032c8cb3901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-064-1062332006410100 BLISTER PACK in 1 BOX, UNIT-DOSE (62332-064-10) / 10 CAPSULE in 1 BLISTER PACK100 blister pack2022-06-120000-00-00NoNoCurrent
62332-064-306233200643030 CAPSULE in 1 BOTTLE (62332-064-30) 30 capsule2022-06-120000-00-00NoNoCurrent
62332-064-606233200646060 CAPSULE in 1 BOTTLE (62332-064-60) 60 capsule2022-06-120000-00-00NoNoCurrent
62332-064-7162332006471500 CAPSULE in 1 BOTTLE (62332-064-71) 500 capsule2022-06-120000-00-00NoNoCurrent
62332-064-91623320064911000 CAPSULE in 1 BOTTLE (62332-064-91) 1000 capsule2022-06-120000-00-00NoNoCurrent