scopolamine trandermal system

Generic: scolopamine transdermal system

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name scopolamine trandermal system
Generic Name scolopamine transdermal system
Labeler bryant ranch prepack
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

scopolamine 1 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8452
Product ID 63629-8452_48bad7e9-60a0-4a48-8688-d8fe755426fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078830
Listing Expiration 2026-12-31
Marketing Start 2017-06-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298452
Hyphenated Format 63629-8452

Supplemental Identifiers

RxCUI
226552
UNII
DL48G20X8X
NUI
N0000175574 N0000175370

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

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (63629-8452-1) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8452-2)
source: ndc

Packages (1)

63629-8452-1 4 POUCH in 1 CARTON (63629-8452-1) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8452-2)

Ingredients (1)

scopolamine (1 mg/1)

Linked Drug Pages (1)

Scopolamine Trandermal System ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "48bad7e9-60a0-4a48-8688-d8fe755426fa", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["DL48G20X8X"], "rxcui": ["226552"], "spl_set_id": ["81c57d46-1617-4295-8a60-acb7e365551c"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (63629-8452-1)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8452-2)", "package_ndc": "63629-8452-1", "marketing_start_date": "20210429"}], "brand_name": "Scopolamine Trandermal System", "product_id": "63629-8452_48bad7e9-60a0-4a48-8688-d8fe755426fa", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "63629-8452", "generic_name": "scolopamine transdermal system", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Scopolamine Trandermal System", "active_ingredients": [{"name": "SCOPOLAMINE", "strength": "1 mg/1"}], "application_number": "ANDA078830", "marketing_category": "ANDA", "marketing_start_date": "20170613", "listing_expiration_date": "20261231"}