Scopolamine Trandermal System

Product NDC
63629-8450
11-digit product format
636298450
Labeler code
63629
Product ID
63629-8450_6499b998-74f4-43c3-b2b6-79ea40ab474f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
scolopamine transdermal system
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Bryant Ranch Prepack
Application
ANDA078830
Marketing category
ANDA
Marketing start
2017-06-13
Substance
SCOPOLAMINE
Active strength
1 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Scopolamine Trandermal System
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SCOPOLAMINE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDL48G20X8X
Rxcui226552

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8450-1Scopolamine Trandermal System24 in 1 CARTONPATCH, EXTENDED RELEASE24106
63629-8450-2Scopolamine Trandermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8450-1EA - Each63629-845008b368ee-59ca-4440-a774-22cedc193e5e12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8450SCOPOLAMINE TRANDERMAL SYSTEM (SCOLOPAMINE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20250316_c89cc74e-9506-48e5-bbb7-26b454b498aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSNc89cc74e-9506-48e5-bbb7-26b454b498aa106
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDc89cc74e-9506-48e5-bbb7-26b454b498aa106
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYc89cc74e-9506-48e5-bbb7-26b454b498aa106
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYc89cc74e-9506-48e5-bbb7-26b454b498aa106
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYc89cc74e-9506-48e5-bbb7-26b454b498aa106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8450-16362984500124 POUCH in 1 CARTON (63629-8450-1) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8450-2) 24 pouch2024-04-040000-00-00NoNoCurrent
63629-8450-2636298450021 in 1 POUCHHistorical