FDA.reportPublic FDA data

Scopolamine Trandermal System

Product NDC
72162-1419
11-digit product format
721621419
Labeler code
72162
Product ID
72162-1419_bf5cc977-efa8-40b8-b227-13ee42f0f374
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
72162-1419-2Scopolamine Trandermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1104
72162-1419-2Scopolamine Trandermal System24 in 1 CARTONPATCH, EXTENDED RELEASE24104
72162-1419-4Scopolamine Trandermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1104
72162-1419-4Scopolamine Trandermal System4 in 1 CARTONPATCH, EXTENDED RELEASE4104
72162-1419-7Scopolamine Trandermal System10 in 1 CARTONPATCH, EXTENDED RELEASE10104
72162-1419-7Scopolamine Trandermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1419-2EA - Each72162-1419cdcce427-c4ec-480e-8761-61f79b48cbd712023-10-16
72162-1419-4EA - Each72162-14192786a608-c903-4552-bcb4-a7d37e21916012024-05-16
72162-1419-7EA - Each72162-1419f70ddf86-2846-4635-91fc-7ef72e83a8a512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1419SCOPOLAMINE TRANDERMAL SYSTEM (SCOLOPAMINE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 6 package rows20240106_69401d6f-3d18-48b0-b28c-a578c9834f32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN69401d6f-3d18-48b0-b28c-a578c9834f32104
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD69401d6f-3d18-48b0-b28c-a578c9834f32104
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY69401d6f-3d18-48b0-b28c-a578c9834f32104
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY69401d6f-3d18-48b0-b28c-a578c9834f32104
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY69401d6f-3d18-48b0-b28c-a578c9834f32104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1419-27216214190224 POUCH in 1 CARTON (72162-1419-2) / 1 PATCH, EXTENDED RELEASE in 1 POUCH24 pouch2023-08-30NoNoCurrent
72162-1419-4721621419044 POUCH in 1 CARTON (72162-1419-4) / 1 PATCH, EXTENDED RELEASE in 1 POUCH4 pouch2023-08-30NoNoCurrent
72162-1419-77216214190710 POUCH in 1 CARTON (72162-1419-7) / 1 PATCH, EXTENDED RELEASE in 1 POUCH10 pouch2023-08-30NoNoCurrent