FDA.reportPublic FDA data

Rivastigmine

Product NDC
70710-1197
11-digit product format
707101197
Labeler code
70710
Product ID
70710-1197_7f578c0e-20d3-4f6d-bb1d-5e99b770ebf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206318
Marketing category
ANDA
Marketing start
2019-03-06
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
70710-1197-1Rivastigmine24 h in 1 POUCHPATCH, EXTENDED RELEASE244
70710-1197-7Rivastigmine30 in 1 CARTONPATCH, EXTENDED RELEASE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1197-1EA - Each70710-11973ebdd9d6-cab6-4aa3-8363-ccf7dd9aeb7312019-05-02
70710-1197-7EA - Each70710-1197a9df4c90-3d28-4200-b64b-188edc9e2b9b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1197RIVASTIGMINE PATCH, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20240601_64dad603-2389-456b-8c18-d1d40b7e7419.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemPSN64dad603-2389-456b-8c18-d1d40b7e74194
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSN64dad603-2389-456b-8c18-d1d40b7e74194
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemPSN64dad603-2389-456b-8c18-d1d40b7e74194
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCD64dad603-2389-456b-8c18-d1d40b7e74194
72502324 HR rivastigmine 0.396 MG/HR Transdermal SystemSCD64dad603-2389-456b-8c18-d1d40b7e74194
130856924 HR rivastigmine 0.554 MG/HR Transdermal SystemSCD64dad603-2389-456b-8c18-d1d40b7e74194
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSY64dad603-2389-456b-8c18-d1d40b7e74194
725023rivastigmine 0.396 MG/HR 24 HR Transdermal PatchSY64dad603-2389-456b-8c18-d1d40b7e74194
1308569rivastigmine 13.3 MG/Day 24HR Transdermal PatchSY64dad603-2389-456b-8c18-d1d40b7e74194
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemSY64dad603-2389-456b-8c18-d1d40b7e74194
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSY64dad603-2389-456b-8c18-d1d40b7e74194
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSY64dad603-2389-456b-8c18-d1d40b7e74194
725023rivastigmine 9.5 MG/Day 24 HR Transdermal PatchSY64dad603-2389-456b-8c18-d1d40b7e74194
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemSY64dad603-2389-456b-8c18-d1d40b7e74194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1197-17071011970124 h in 1 POUCH24 hHistorical
70710-1197-77071011970730 POUCH in 1 CARTON (70710-1197-7) / 24 h in 1 POUCH (70710-1197-1) 30 pouch2019-03-060000-00-00NoNoCurrent