FDA.reportPublic FDA data

Scopolamine

Product NDC
50090-5349
11-digit product format
500905349
Labeler code
50090
Product ID
50090-5349_0d975b5a-2168-45c5-8c36-d28210d84161
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
scopolamine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
A-S Medication Solutions
Application
ANDA203753
Marketing category
ANDA
Marketing start
2019-06-19
Substance
SCOPOLAMINE
Active strength
1 mg/3d
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
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5349-02023-02-07C16284748780-1f386c649-dc96-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SCOPOLAMINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for SCOPOLAMINE TRANSDERMAL SYSTEM . SCOPOLAMINE transdermal system Initial U.S. Approval: 1979
50090-5349-02023-01-30C16284748780-1f386c649-dc96-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SCOPOLAMINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for SCOPOLAMINE TRANSDERMAL SYSTEM . SCOPOLAMINE transdermal system Initial U.S. Approval: 1979

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5349-0Scopolamine1 d in 1 POUCHPATCH16
50090-5349-0Scopolamine4 in 1 CARTONPATCH46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5349-0EA - Each50090-53494c1eee4b-e1da-4e42-a403-ff7b02c2c20712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5349SCOPOLAMINE PATCH [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20230722_b24c2315-c947-4ad2-89fe-8dc0c45e221b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSNb24c2315-c947-4ad2-89fe-8dc0c45e221b6
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDb24c2315-c947-4ad2-89fe-8dc0c45e221b6
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYb24c2315-c947-4ad2-89fe-8dc0c45e221b6
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYb24c2315-c947-4ad2-89fe-8dc0c45e221b6
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYb24c2315-c947-4ad2-89fe-8dc0c45e221b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5349-0500905349004 POUCH in 1 CARTON (50090-5349-0) / 1 d in 1 POUCH4 pouch2020-11-090000-00-00NoNoCurrent