Scopolamine Trandermal System

Product NDC
63629-8451
11-digit product format
636298451
Labeler code
63629
Product ID
63629-8451_31757cae-a379-4680-9f6e-404b57071f20
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
63629-8451-1Scopolamine Trandermal System10 in 1 CARTONPATCH, EXTENDED RELEASE10107
63629-8451-2Scopolamine Trandermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8451-1EA - Each63629-84513e2c4216-ad63-4bec-9c72-d2f9adea321412021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8451SCOPOLAMINE TRANDERMAL SYSTEM (SCOLOPAMINE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 2 package rows20250316_1099a330-fcb8-4acd-9ef8-525024c6b9d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN1099a330-fcb8-4acd-9ef8-525024c6b9d6107
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD1099a330-fcb8-4acd-9ef8-525024c6b9d6107
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY1099a330-fcb8-4acd-9ef8-525024c6b9d6107
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY1099a330-fcb8-4acd-9ef8-525024c6b9d6107
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY1099a330-fcb8-4acd-9ef8-525024c6b9d6107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8451-16362984510110 POUCH in 1 CARTON (63629-8451-1) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8451-2) 10 pouch2021-04-290000-00-00NoNoCurrent
63629-8451-2636298451021 in 1 POUCHHistorical