FDA.reportPublic FDA data

Rivastigmine

Product NDC
16714-116
11-digit product format
167140116
Labeler code
16714
Product ID
16714-116_eb0de734-0cf3-4e83-b14e-feebe76390e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Northstar Rx LLC.
Application
ANDA206318
Marketing category
ANDA
Marketing start
2019-10-01
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
16714-116-01Rivastigmine24 h in 1 POUCHPATCH, EXTENDED RELEASE247
16714-116-02Rivastigmine30 in 1 CARTONPATCH, EXTENDED RELEASE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-116-01EA - Each16714-116021d308e-0214-47b0-92a7-6eb4b194e57912020-02-13
16714-116-02EA - Each16714-11686e014af-4471-4970-ab83-b684e22adb4112020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-116RIVASTIGMINE PATCH, EXTENDED RELEASE [NORTHSTAR RX LLC.]6Current NDC, Legacy NDC, 2 package rows20240920_8b809739-8381-4cc1-ab4a-5b17ab902a3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemPSN8b809739-8381-4cc1-ab4a-5b17ab902a3d7
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSN8b809739-8381-4cc1-ab4a-5b17ab902a3d7
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemPSN8b809739-8381-4cc1-ab4a-5b17ab902a3d7
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCD8b809739-8381-4cc1-ab4a-5b17ab902a3d7
72502324 HR rivastigmine 0.396 MG/HR Transdermal SystemSCD8b809739-8381-4cc1-ab4a-5b17ab902a3d7
130856924 HR rivastigmine 0.554 MG/HR Transdermal SystemSCD8b809739-8381-4cc1-ab4a-5b17ab902a3d7
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSY8b809739-8381-4cc1-ab4a-5b17ab902a3d7
725023rivastigmine 0.396 MG/HR 24 HR Transdermal PatchSY8b809739-8381-4cc1-ab4a-5b17ab902a3d7
1308569rivastigmine 13.3 MG/Day 24HR Transdermal PatchSY8b809739-8381-4cc1-ab4a-5b17ab902a3d7
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemSY8b809739-8381-4cc1-ab4a-5b17ab902a3d7
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSY8b809739-8381-4cc1-ab4a-5b17ab902a3d7
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSY8b809739-8381-4cc1-ab4a-5b17ab902a3d7
725023rivastigmine 9.5 MG/Day 24 HR Transdermal PatchSY8b809739-8381-4cc1-ab4a-5b17ab902a3d7
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemSY8b809739-8381-4cc1-ab4a-5b17ab902a3d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-116-011671401160124 h in 1 POUCH24 hHistorical
16714-116-021671401160230 POUCH in 1 CARTON (16714-116-02) / 24 h in 1 POUCH (16714-116-01) 30 pouch2019-10-010000-00-00NoNoCurrent