scopolamine

Generic: scopolamine

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name scopolamine
Generic Name scopolamine
Labeler mylan pharmaceuticals inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

scopolamine 1 mg/3d

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6470
Product ID 0378-6470_79930eea-4bac-4412-871f-5cd0933bef05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203753
Listing Expiration 2026-12-31
Marketing Start 2019-06-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786470
Hyphenated Format 0378-6470

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 ANDA203753 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/3d
source: ndc
Packaging
  • 24 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
  • 10 POUCH in 1 CARTON (0378-6470-97) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
  • 4 POUCH in 1 CARTON (0378-6470-99) / 1 PATCH in 1 POUCH (0378-6470-16) / 3 d in 1 PATCH
source: ndc

Packages (3)

0378-6470-44 24 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH 0378-6470-97 10 POUCH in 1 CARTON (0378-6470-97) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH 0378-6470-99 4 POUCH in 1 CARTON (0378-6470-99) / 1 PATCH in 1 POUCH (0378-6470-16) / 3 d in 1 PATCH

Ingredients (1)

scopolamine (1 mg/3d)

Linked Drug Pages (1)

Scopolamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "79930eea-4bac-4412-871f-5cd0933bef05", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["DL48G20X8X"], "rxcui": ["226552"], "spl_set_id": ["163accb7-45e6-4d97-844d-72b606677008"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CARTON (0378-6470-44)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH", "package_ndc": "0378-6470-44", "marketing_start_date": "20190619"}, {"sample": false, "description": "10 POUCH in 1 CARTON (0378-6470-97)  / 1 PATCH in 1 POUCH / 3 d in 1 PATCH", "package_ndc": "0378-6470-97", "marketing_start_date": "20190619"}, {"sample": false, "description": "4 POUCH in 1 CARTON (0378-6470-99)  / 1 PATCH in 1 POUCH (0378-6470-16)  / 3 d in 1 PATCH", "package_ndc": "0378-6470-99", "marketing_start_date": "20190619"}], "brand_name": "Scopolamine", "product_id": "0378-6470_79930eea-4bac-4412-871f-5cd0933bef05", "dosage_form": "PATCH", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0378-6470", "generic_name": "scopolamine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Scopolamine", "active_ingredients": [{"name": "SCOPOLAMINE", "strength": "1 mg/3d"}], "application_number": "ANDA203753", "marketing_category": "ANDA", "marketing_start_date": "20190619", "listing_expiration_date": "20261231"}