rivastigmine transdermal system

Generic: rivastigmine

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rivastigmine transdermal system
Generic Name rivastigmine
Labeler breckenridge pharmaceutical, inc.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

rivastigmine 4.6 mg/24h

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-897
Product ID 51991-897_6c0c606b-108e-4837-8533-f485f9e4ee4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209063
Listing Expiration 2026-12-31
Marketing Start 2019-12-19

Pharmacologic Class

Established (EPC)
cholinesterase inhibitor [epc]
Mechanism of Action
cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51991897
Hyphenated Format 51991-897

Supplemental Identifiers

RxCUI
725021 725023 1308569
UPC
0351991899303
UNII
PKI06M3IW0
NUI
N0000175723 N0000000177

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rivastigmine transdermal system (source: ndc)
Generic Name rivastigmine (source: ndc)
Application Number ANDA209063 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 4.6 mg/24h
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (51991-897-30) / 1 PATCH in 1 POUCH (51991-897-99) / 24 h in 1 PATCH
source: ndc

Packages (1)

51991-897-30 30 POUCH in 1 CARTON (51991-897-30) / 1 PATCH in 1 POUCH (51991-897-99) / 24 h in 1 PATCH

Ingredients (1)

rivastigmine (4.6 mg/24h)

Linked Drug Pages (1)

Rivastigmine Transdermal System ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "6c0c606b-108e-4837-8533-f485f9e4ee4b", "openfda": {"nui": ["N0000175723", "N0000000177"], "upc": ["0351991899303"], "unii": ["PKI06M3IW0"], "rxcui": ["725021", "725023", "1308569"], "spl_set_id": ["b201fe68-b5e5-4a6f-8cf1-069543f03e76"], "pharm_class_epc": ["Cholinesterase Inhibitor [EPC]"], "pharm_class_moa": ["Cholinesterase Inhibitors [MoA]"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (51991-897-30)  / 1 PATCH in 1 POUCH (51991-897-99)  / 24 h in 1 PATCH", "package_ndc": "51991-897-30", "marketing_start_date": "20191219"}], "brand_name": "Rivastigmine Transdermal System", "product_id": "51991-897_6c0c606b-108e-4837-8533-f485f9e4ee4b", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "51991-897", "generic_name": "Rivastigmine", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rivastigmine Transdermal System", "active_ingredients": [{"name": "RIVASTIGMINE", "strength": "4.6 mg/24h"}], "application_number": "ANDA209063", "marketing_category": "ANDA", "marketing_start_date": "20191219", "listing_expiration_date": "20261231"}