Scopolamine

Product NDC
72162-2453
11-digit product format
721622453
Labeler code
72162
Product ID
72162-2453_4a095aed-7863-4738-8619-04b10bcfeb6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Bryant Ranch Prepack
Application
ANDA215329
Marketing category
ANDA
Marketing start
2024-11-01
Substance
SCOPOLAMINE
Active strength
1 mg/3d
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Scopolamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SCOPOLAMINE1 mg/3d

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
72162-2453-2Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE1102
72162-2453-2Scopolamine4 in 1 BOXPATCH, EXTENDED RELEASE4102
72162-2453-4Scopolamine10 in 1 BOXPATCH, EXTENDED RELEASE10102
72162-2453-4Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE1102
72162-2453-7Scopolamine24 in 1 BOXPATCH, EXTENDED RELEASE24102
72162-2453-7Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2453-2EA - Each72162-2453c2220971-d973-464f-baec-dda7a848718e12025-03-04
72162-2453-4EA - Each72162-245386a19819-e624-4e62-ae28-c082d7f7799b12025-03-04
72162-2453-7EA - Each72162-2453ca1fd8d7-73c3-4d13-8391-bd332e66b20012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2453SCOPOLAMINE PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 6 package rows20250130_a472ee74-76a7-470f-8564-9018940a82e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSNa472ee74-76a7-470f-8564-9018940a82e8102
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDa472ee74-76a7-470f-8564-9018940a82e8102
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYa472ee74-76a7-470f-8564-9018940a82e8102
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYa472ee74-76a7-470f-8564-9018940a82e8102
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYa472ee74-76a7-470f-8564-9018940a82e8102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2453-2721622453024 POUCH in 1 BOX (72162-2453-2) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH4 pouch2025-01-28NoNoHistorical
72162-2453-47216224530410 POUCH in 1 BOX (72162-2453-4) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH10 pouch2025-01-28NoNoHistorical
72162-2453-77216224530724 POUCH in 1 BOX (72162-2453-7) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH24 pouch2025-01-28NoNoHistorical