scopolamine transdermal system

Generic: scopolamine transdermal system

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name scopolamine transdermal system
Generic Name scopolamine transdermal system
Labeler padagis israel pharmaceuticals ltd
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

scopolamine 1 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-580
Product ID 45802-580_d334a21d-7546-477f-a66a-f95b2cf523ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078830
Marketing Start 2017-06-13
Marketing End 2028-06-30

Pharmacologic Class

Established (EPC)
anticholinergic [epc]
Mechanism of Action
cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802580
Hyphenated Format 45802-580

Supplemental Identifiers

RxCUI
226552
UNII
DL48G20X8X
NUI
N0000175574 N0000175370

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 scopolamine transdermal system (source: ndc)
Generic Name scopolamine transdermal system (source: ndc)
Application Number ANDA078830 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
  • 24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
  • 4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
source: ndc

Packages (3)

45802-580-46 10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH 45802-580-62 24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH 45802-580-84 4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH

Ingredients (1)

scopolamine (1 mg/1)

Linked Drug Pages (1)

Scopolamine Transdermal System ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "d334a21d-7546-477f-a66a-f95b2cf523ce", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["DL48G20X8X"], "rxcui": ["226552"], "spl_set_id": ["cb93bfad-3e37-4a27-92f6-f21703ae7bdf"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (45802-580-46)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH", "package_ndc": "45802-580-46", "marketing_end_date": "20280630", "marketing_start_date": "20170613"}, {"sample": false, "description": "24 POUCH in 1 CARTON (45802-580-62)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH", "package_ndc": "45802-580-62", "marketing_end_date": "20280630", "marketing_start_date": "20170613"}, {"sample": false, "description": "4 POUCH in 1 CARTON (45802-580-84)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH", "package_ndc": "45802-580-84", "marketing_end_date": "20280630", "marketing_start_date": "20170613"}], "brand_name": "Scopolamine Transdermal System", "product_id": "45802-580_d334a21d-7546-477f-a66a-f95b2cf523ce", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "45802-580", "generic_name": "scopolamine transdermal system", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Scopolamine Transdermal System", "active_ingredients": [{"name": "SCOPOLAMINE", "strength": "1 mg/1"}], "application_number": "ANDA078830", "marketing_category": "ANDA", "marketing_end_date": "20280630", "marketing_start_date": "20170613"}