FDA.reportPublic FDA data

Rivastigmine Tartrate

Product NDC
71209-013
11-digit product format
712090013
Labeler code
71209
Product ID
71209-013_862f0b42-695e-4170-983d-cfb848967cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA203844
Marketing category
ANDA
Marketing start
2014-02-11
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
71209-013-03Rivastigmine Tartrate60 in 1 BOTTLECAPSULE606
71209-013-10Rivastigmine Tartrate500 in 1 BOTTLECAPSULE5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-013RIVASTIGMINE TARTRATE CAPSULE [CADILA PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 2 package rows20221230_e7e641fe-39bd-4681-a430-6dedeb6d6af5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314214rivastigmine tartrate 1.5 MG Oral CapsulePSNe7e641fe-39bd-4681-a430-6dedeb6d6af56
312835rivastigmine tartrate 3 MG Oral CapsulePSNe7e641fe-39bd-4681-a430-6dedeb6d6af56
314215rivastigmine tartrate 4.5 MG Oral CapsulePSNe7e641fe-39bd-4681-a430-6dedeb6d6af56
312836rivastigmine tartrate 6 MG Oral CapsulePSNe7e641fe-39bd-4681-a430-6dedeb6d6af56
314214rivastigmine 1.5 MG Oral CapsuleSCDe7e641fe-39bd-4681-a430-6dedeb6d6af56
312835rivastigmine 3 MG Oral CapsuleSCDe7e641fe-39bd-4681-a430-6dedeb6d6af56
314215rivastigmine 4.5 MG Oral CapsuleSCDe7e641fe-39bd-4681-a430-6dedeb6d6af56
312836rivastigmine 6 MG Oral CapsuleSCDe7e641fe-39bd-4681-a430-6dedeb6d6af56
314214rivastigmine 1.5 MG (as rivastigmine tartrate) Oral CapsuleSYe7e641fe-39bd-4681-a430-6dedeb6d6af56
312835rivastigmine 3 MG (as rivastigmine tartrate) Oral CapsuleSYe7e641fe-39bd-4681-a430-6dedeb6d6af56
314215rivastigmine 4.5 MG (as rivastigmine tartrate) Oral CapsuleSYe7e641fe-39bd-4681-a430-6dedeb6d6af56
312836rivastigmine 6 MG (as rivastigmine tartrate) Oral CapsuleSYe7e641fe-39bd-4681-a430-6dedeb6d6af56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-013-037120900130360 CAPSULE in 1 BOTTLE (71209-013-03) 60 capsule2014-02-110000-00-00NoNoCurrent
71209-013-1071209001310500 CAPSULE in 1 BOTTLE (71209-013-10) 500 capsule2014-02-110000-00-00NoNoCurrent