Scopolamine

Manufacturer
Zydus Lifesciences Limited
Effective date
2025-08-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 21:41:01

Label at a glance#

ProductScopolamine
Active ingredientSCOPOLAMINE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Scopolamine transdermal system, 1 mg/3 days

Carton of 4 transdermal systems

NDC 70771-1787-4

Rx only

4's carton
4's carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN3
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD3
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY3
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY3
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SCOPOLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-178770771-1787-2, 70771-1787-7, 70771-1787-1, 70771-1787-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SCOPOLAMINEDL48G20X8XACTIB
POVIDONE K30U725QWY32XIACT
DIMETHICONE92RU3N3Y1OIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217893-001SCOPOLAMINESCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217893-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29c2088c7a36db…
2026-09-14 22:38:342026-08A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-2984e616aacf4f…
2026-08-18 06:07:402026-07A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217893-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2024-08-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A217893-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A217893-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A217893-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217893-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217893-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217893-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217893-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217893-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217893-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217893-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217893-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217893-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217893-001AB1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217893-001AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ScopolamineSCOPOLAMINEZydus Lifesciences Limited016df9f3-61d5-45e9-b1d6-791a5d2f26d52025-08-23Exact identifier
ndc (package): 70771-1787-1
ndc (package): 70771-1787-2
ndc (package): 70771-1787-7
ndc (package): 70771-1787-4
ndc (product): 70771-1787
ndc11 (package): 70771178702
ndc11 (package): 70771178704
ndc11 (package): 70771178701
ndc11 (package): 70771178707
spl id: 2bd0ca3f-183d-4af2-8c0e-962115d97fed
spl set id: 016df9f3-61d5-45e9-b1d6-791a5d2f26d5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.