scopolamine

Generic: scopolamine

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name scopolamine
Generic Name scopolamine
Labeler ingenus pharmaceuticals, llc
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

scopolamine 1.5 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-505
Product ID 50742-505_4c2816f0-78a7-476c-baa3-438d3873a92c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212342
Listing Expiration 2027-12-31
Marketing Start 2020-11-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742505
Hyphenated Format 50742-505

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 (source: ndc)
Generic Name scopolamine (source: ndc)
Application Number ANDA212342 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (50742-505-04) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
  • 10 POUCH in 1 CARTON (50742-505-10) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
  • 24 POUCH in 1 CARTON (50742-505-24) / 1 PATCH, EXTENDED RELEASE in 1 POUCH
source: ndc

Packages (3)

50742-505-04 4 POUCH in 1 CARTON (50742-505-04) / 1 PATCH, EXTENDED RELEASE in 1 POUCH 50742-505-10 10 POUCH in 1 CARTON (50742-505-10) / 1 PATCH, EXTENDED RELEASE in 1 POUCH 50742-505-24 24 POUCH in 1 CARTON (50742-505-24) / 1 PATCH, EXTENDED RELEASE in 1 POUCH

Ingredients (1)

scopolamine (1.5 mg/1)

Linked Drug Pages (1)

Scopolamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "4c2816f0-78a7-476c-baa3-438d3873a92c", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["DL48G20X8X"], "rxcui": ["226552"], "spl_set_id": ["2a6f9aaf-a70a-481f-a82b-1dcaaadc185b"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (50742-505-04)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH", "package_ndc": "50742-505-04", "marketing_start_date": "20201124"}, {"sample": false, "description": "10 POUCH in 1 CARTON (50742-505-10)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH", "package_ndc": "50742-505-10", "marketing_start_date": "20201124"}, {"sample": false, "description": "24 POUCH in 1 CARTON (50742-505-24)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH", "package_ndc": "50742-505-24", "marketing_start_date": "20201124"}], "brand_name": "Scopolamine", "product_id": "50742-505_4c2816f0-78a7-476c-baa3-438d3873a92c", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "50742-505", "generic_name": "Scopolamine", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Scopolamine", "active_ingredients": [{"name": "SCOPOLAMINE", "strength": "1.5 mg/1"}], "application_number": "ANDA212342", "marketing_category": "ANDA", "marketing_start_date": "20201124", "listing_expiration_date": "20271231"}