FDA.reportPublic FDA data

Rivastigmine Tartrate

Product NDC
0904-7107
11-digit product format
009047107
Labeler code
0904
Product ID
0904-7107_65cfb382-8f01-4ee8-8235-8ce2f5d3beec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204572
Marketing category
ANDA
Marketing start
2016-03-25
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
Rxcui314214

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
0904-7107-61Rivastigmine Tartrate100 in 1 CARTONCAPSULE1004
0904-7107-61Rivastigmine Tartrate1 in 1 BLISTER PACKCAPSULE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7107-61EA - Each0904-710781092c7a-1d55-4bb6-b610-f5dd0f8146c112021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7107RIVASTIGMINE TARTRATE CAPSULE [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250308_39aadc39-0f4f-44f7-88de-83a0ea2ac332.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSN39aadc39-0f4f-44f7-88de-83a0ea2ac3324
314214rivastigmine 1.5 MG Oral CapsuleSCD39aadc39-0f4f-44f7-88de-83a0ea2ac3324
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSY39aadc39-0f4f-44f7-88de-83a0ea2ac3324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7107-6100904710761100 BLISTER PACK in 1 CARTON (0904-7107-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2016-03-250000-00-00NoNoCurrent