FDA.reportPublic FDA data

Rivastigmine

Product NDC
0378-9071
11-digit product format
003789071
Labeler code
0378
Product ID
0378-9071_c1d8c8a9-87e9-4ca1-ba70-4a7467205fd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rivastigmine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA205622
Marketing category
ANDA
Marketing start
2018-06-20
Substance
RIVASTIGMINE
Active strength
9.5 mg/24h
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVASTIGMINE9.5 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPKI06M3IW0
Rxcui725021, 725023, 1308569

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
0378-9071-16Rivastigmine24 h in 1 PATCHPATCH2410
0378-9071-16Rivastigmine1 in 1 POUCHPATCH110
0378-9071-93Rivastigmine30 in 1 CARTONPATCH3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9071-16EA - Each0378-90716f4b64bb-bcae-403f-9ad6-5c1c8a9e808912019-04-11
0378-9071-93EA - Each0378-9071bdf7832a-329a-431c-ad0b-4bf7119d684a12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9071RIVASTIGMINE PATCH [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 3 package rows20241027_4ab335d1-19ee-4cd9-9776-8086645d19e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemPSN4ab335d1-19ee-4cd9-9776-8086645d19e410
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSN4ab335d1-19ee-4cd9-9776-8086645d19e410
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemPSN4ab335d1-19ee-4cd9-9776-8086645d19e410
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCD4ab335d1-19ee-4cd9-9776-8086645d19e410
72502324 HR rivastigmine 0.396 MG/HR Transdermal SystemSCD4ab335d1-19ee-4cd9-9776-8086645d19e410
130856924 HR rivastigmine 0.554 MG/HR Transdermal SystemSCD4ab335d1-19ee-4cd9-9776-8086645d19e410
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSY4ab335d1-19ee-4cd9-9776-8086645d19e410
725023rivastigmine 0.396 MG/HR 24 HR Transdermal PatchSY4ab335d1-19ee-4cd9-9776-8086645d19e410
1308569rivastigmine 13.3 MG/Day 24HR Transdermal PatchSY4ab335d1-19ee-4cd9-9776-8086645d19e410
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemSY4ab335d1-19ee-4cd9-9776-8086645d19e410
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSY4ab335d1-19ee-4cd9-9776-8086645d19e410
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSY4ab335d1-19ee-4cd9-9776-8086645d19e410
725023rivastigmine 9.5 MG/Day 24 HR Transdermal PatchSY4ab335d1-19ee-4cd9-9776-8086645d19e410
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemSY4ab335d1-19ee-4cd9-9776-8086645d19e410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9071-160037890711624 h in 1 PATCH24 hHistorical
0378-9071-930037890719330 POUCH in 1 CARTON (0378-9071-93) / 1 PATCH in 1 POUCH (0378-9071-16) / 24 h in 1 PATCH30 pouch2018-06-200000-00-00NoNoCurrent