Scopolamine

Product NDC
71335-3013
11-digit product format
713353013
Labeler code
71335
Product ID
71335-3013_8b4f4ea0-9cdc-429a-afe2-47905dee0484
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
71335-3013-1Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE1101
71335-3013-1Scopolamine4 in 1 BOXPATCH, EXTENDED RELEASE4101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3013-1EA - Each71335-301327737a56-ba88-49f4-af8a-17d43e6df34312026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSNdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3013-1713353013014 POUCH in 1 BOX (71335-3013-1) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH4 pouch2025-11-18NoNoHistorical