FDA.reportPublic FDA data

Scopolamine

Product NDC
70771-1787
11-digit product format
707711787
Labeler code
70771
Product ID
70771-1787_2bd0ca3f-183d-4af2-8c0e-962115d97fed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Zydus Lifesciences Limited
Application
ANDA217893
Marketing category
ANDA
Marketing start
2024-09-05
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
70771-1787-1Scopolamine3 d in 1 PATCHPATCH, EXTENDED RELEASE33
70771-1787-1Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE13
70771-1787-2Scopolamine10 in 1 CARTONPATCH, EXTENDED RELEASE103
70771-1787-2Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE13
70771-1787-4Scopolamine4 in 1 CARTONPATCH, EXTENDED RELEASE43
70771-1787-7Scopolamine24 in 1 CARTONPATCH, EXTENDED RELEASE243
70771-1787-7Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1787SCOPOLAMINE PATCH, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 7 package rows20241013_016df9f3-61d5-45e9-b1d6-791a5d2f26d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN016df9f3-61d5-45e9-b1d6-791a5d2f26d53
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD016df9f3-61d5-45e9-b1d6-791a5d2f26d53
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY016df9f3-61d5-45e9-b1d6-791a5d2f26d53
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY016df9f3-61d5-45e9-b1d6-791a5d2f26d53
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY016df9f3-61d5-45e9-b1d6-791a5d2f26d53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1787-1707711787013 d in 1 PATCH3 dHistorical
70771-1787-27077117870210 POUCH in 1 CARTON (70771-1787-2) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH10 pouch2024-09-05NoNoHistorical
70771-1787-4707711787044 POUCH in 1 CARTON (70771-1787-4) / 1 PATCH in 1 POUCH (70771-1787-1) / 3 d in 1 PATCH4 pouch2024-09-05NoNoHistorical
70771-1787-77077117870724 POUCH in 1 CARTON (70771-1787-7) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH24 pouch2024-09-05NoNoHistorical