FDA.reportPublic FDA data

RIVASTIGMINE TARTRATE

Product NDC
75834-133
11-digit product format
758340133
Labeler code
75834
Product ID
75834-133_e272f7d1-d782-4ff1-919c-784c91ee024d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVASTIGMINE TARTRATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA203844
Marketing category
ANDA
Marketing start
2017-09-04
Substance
RIVASTIGMINE TARTRATE
Active strength
1.5 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 TARTRATE1.5 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-133-052022-02-16C16284748780-19d75b9d0-8cf8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES USP safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES USP. RIVASTIGMINE TARTRATE capsules for oral use Initial U.S. Approval: 2000
75834-133-602022-02-16C16284748780-19d75b9d0-8cf8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES USP safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES USP. RIVASTIGMINE TARTRATE capsules for oral use Initial U.S. Approval: 2000
75834-133-052022-01-28C16284748780-19d75b9d0-8cf8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES USP safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES USP. RIVASTIGMINE TARTRATE capsules for oral use Initial U.S. Approval: 2000
75834-133-602022-01-28C16284748780-19d75b9d0-8cf8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES USP safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES USP. RIVASTIGMINE TARTRATE capsules for oral use Initial U.S. Approval: 2000
75834-133-052020-05-06C16284748780-19d75b9d0-8cf8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES USP safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES USP. RIVASTIGMINE TARTRATE capsules for oral use Initial U.S. Approval: 2000
75834-133-602020-05-06C16284748780-19d75b9d0-8cf8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES USP safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES USP. RIVASTIGMINE TARTRATE capsules for oral use Initial U.S. Approval: 2000
75834-133-052020-01-31C16284748780-19d75b9d0-8cf8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES USP safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES USP. RIVASTIGMINE TARTRATE capsules for oral use Initial U.S. Approval: 2000
75834-133-602020-01-31C16284748780-19d75b9d0-8cf8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES USP safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES USP. RIVASTIGMINE TARTRATE capsules for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-133-05RIVASTIGMINE TARTRATE500 in 1 BOTTLE, PLASTICCAPSULE5003
75834-133-60RIVASTIGMINE TARTRATE60 in 1 BOTTLE, PLASTICCAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-133-05EA - Each75834-1330db9c77d-3dfc-4546-bd12-f1d9108a6b9312017-11-06
75834-133-60EA - Each75834-133a6c6711d-c47a-4ad5-ab52-091569825ece12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-133RIVASTIGMINE TARTRATE CAPSULE [NIVAGEN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20220217_83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSN83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
312835rivastigmine tartrate 3 MG Oral CapsulePSN83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
314215rivastigmine tartrate 4.5 MG Oral CapsulePSN83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
312836rivastigmine tartrate 6 MG Oral CapsulePSN83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
314214rivastigmine 1.5 MG Oral CapsuleSCD83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
312835rivastigmine 3 MG Oral CapsuleSCD83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
314215rivastigmine 4.5 MG Oral CapsuleSCD83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
312836rivastigmine 6 MG Oral CapsuleSCD83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSY83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSY83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSY83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSY83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-133-0575834013305500 CAPSULE in 1 BOTTLE, PLASTIC (75834-133-05) 500 capsule2017-09-040000-00-00NoNoCurrent
75834-133-607583401336060 CAPSULE in 1 BOTTLE, PLASTIC (75834-133-60) 60 capsule2017-09-040000-00-00NoNoCurrent