Scopolamine

Product NDC
68071-3994
11-digit product format
680713994
Labeler code
68071
Product ID
68071-3994_51288b87-a0ea-5505-e063-6394a90a3736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA212342
Marketing category
ANDA
Marketing start
2020-11-24
Substance
SCOPOLAMINE
Active strength
1.5 mg/1
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
SCOPOLAMINE1.5 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
68071-3994-4Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE11
68071-3994-4Scopolamine4 in 1 CARTONPATCH, EXTENDED RELEASE41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN51289d8b-f7e3-a3e0-e063-6294a90add431
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD51289d8b-f7e3-a3e0-e063-6294a90add431
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY51289d8b-f7e3-a3e0-e063-6294a90add431
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY51289d8b-f7e3-a3e0-e063-6294a90add431
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY51289d8b-f7e3-a3e0-e063-6294a90add431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3994-4680713994044 POUCH in 1 CARTON (68071-3994-4) / 1 PATCH, EXTENDED RELEASE in 1 POUCH4 pouch2026-05-06NoNoHistorical