scopolamine

Product NDC
0591-2258
11-digit product format
005912258
Labeler code
0591
Product ID
0591-2258_59f10193-3604-4f3c-a9f7-68a55004f3d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
scopolamine
Dosage form
SYSTEM
Route
TRANSDERMAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208769
Marketing category
ANDA
Marketing start
2022-05-12
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2258-04scopolamine4 in 1 CARTONSYSTEM44
0591-2258-04scopolamine1 in 1 POUCHSYSTEM14
0591-2258-23scopolamine1 in 1 POUCHSYSTEM14
0591-2258-23scopolamine24 in 1 CARTONSYSTEM244
0591-2258-79scopolamine1 in 1 POUCHSYSTEM14
0591-2258-79scopolamine10 in 1 CARTONSYSTEM104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2258-04EA - Each0591-22588582207d-925e-402b-9667-5fec5abd14a112022-06-06
0591-2258-23EA - Each0591-2258ccfd53da-8a48-4e7a-806d-426f19b4952112022-06-06
0591-2258-79EA - Each0591-22582319f4d1-ddd5-4747-baec-d34b3c77110e12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2258SCOPOLAMINE SYSTEM [ACTAVIS PHARMA, INC.]3Current NDC, Legacy NDC, 6 package rows20240905_800b6421-48eb-47f5-b255-c12f75e59068.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN800b6421-48eb-47f5-b255-c12f75e590684
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD800b6421-48eb-47f5-b255-c12f75e590684
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY800b6421-48eb-47f5-b255-c12f75e590684
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY800b6421-48eb-47f5-b255-c12f75e590684
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY800b6421-48eb-47f5-b255-c12f75e590684
226552scopolamine 1 MG 3 Day Transdermal SystemPSN5c232a94-0842-4efc-98a6-9d23e3b15a763
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD5c232a94-0842-4efc-98a6-9d23e3b15a763
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY5c232a94-0842-4efc-98a6-9d23e3b15a763
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY5c232a94-0842-4efc-98a6-9d23e3b15a763
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY5c232a94-0842-4efc-98a6-9d23e3b15a763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2258-04005912258044 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH4 pouch2022-05-120000-00-00NoNoCurrent
0591-2258-230059122582324 POUCH in 1 CARTON (0591-2258-23) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH24 pouch2022-05-120000-00-00NoNoCurrent
0591-2258-790059122587910 POUCH in 1 CARTON (0591-2258-79) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH10 pouch2022-05-120000-00-00NoNoCurrent