FDA.reportPublic FDA data

NDC 0378-9072-16 - Rivastigmine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0378-9072
Requested NDC
0378-9072-16
Package NDCs from labels
0378-9072-16, 0378-9072-93
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-09-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rivastigmine - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-09-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-9072-16Rivastigmine24 h in 1 PATCHPATCH2410
0378-9072-16Rivastigmine1 in 1 POUCHPATCH110
0378-9072-93Rivastigmine30 in 1 CARTONPATCH3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9072RIVASTIGMINE PATCH [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 3 package rows20241027_4ab335d1-19ee-4cd9-9776-8086645d19e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9072-16EA - Each0378-9072abb14a85-0014-4176-935c-4e32e0f7826212019-10-07
0378-9072-93EA - Each0378-9072666f3027-9917-4851-a6ae-0da8e40b47a512018-07-03

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 15 of 21 · 404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
unii: F05Q2T2JA0
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with LaxativeDOCUSATE SODIUM AND SENNOSIDESBryant Ranch Prepacke24638d3-7738-4185-8ce9-1845d8594cc62024-11-04WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c61c71-9a23-4bd3-e053-2a95a90ad4602024-10-26WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMA-S Medication Solutionsef05ad45-7082-43e6-9533-a79c5aa0f3732024-10-22WarningsExact identifier
unii: F05Q2T2JA0
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
unii: F05Q2T2JA0
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP8678a3ee-0e2c-4c95-ad2e-83aa601f32382024-10-01WarningsExact identifier
unii: F05Q2T2JA0
Pedia-LaxDOCUSATE SODIUMC.B. Fleet Company, Inc.0e908bea-ebab-44e7-919c-90002e6f5d422024-10-01WarningsExact identifier
unii: F05Q2T2JA0
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: E1NC1JVS3O
Natural Vegetable Laxative and Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c562e1-4080-44cb-e053-2a95a90a42222024-09-25WarningsExact identifier
unii: F05Q2T2JA0
RivastigmineRIVASTIGMINEMylan Pharmaceuticals Inc.4ab335d1-19ee-4cd9-9776-8086645d19e42024-09-21Warnings, Adverse reactionsExact identifier
application number: ANDA205622
ndc (package): 0378-9071-93
ndc (package): 0378-9070-93
ndc (package): 0378-9072-16
ndc (package): 0378-9072-93
ndc (package): 0378-9071-16
ndc (package): 0378-9070-16
ndc (product): 0378-9070
ndc (product): 0378-9072
ndc (product): 0378-9071
ndc11 (package): 00378907216
rxcui: 725021
rxcui: 1308569
rxcui: 725023
spl id: c1d8c8a9-87e9-4ca1-ba70-4a7467205fd4
spl set id: 4ab335d1-19ee-4cd9-9776-8086645d19e4
unii: PKI06M3IW0
SENNA-S LAXATIVE WITH STOOL SOFTENERSENNOSIDESBasic Drugs, Inc.d32b9956-fc04-8d64-e053-2a95a90a17b32024-09-14WarningsExact identifier
unii: F05Q2T2JA0
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.