FDA.reportPublic FDA data

Scopolamine

Product NDC
69238-1662
11-digit product format
692381662
Labeler code
69238
Product ID
69238-1662_eef82f5e-a712-475a-9206-91891d462bee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA218384
Marketing category
ANDA
Marketing start
2025-06-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A218384-001SCOPOLAMINESCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2025-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218384-001AB

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
2026-02-19 14:30 UTC2026-02A218384-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2025-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218384-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2025-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A218384-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2025-06-096a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218384-001SCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALAB2025-06-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218384-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218384-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218384-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218384-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DL48G20X8XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
226552Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48e6e53a-d904-475b-84dd-6068cc0cb36bAvailable on FDA.report

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
69238-1662-2Scopolamine3 d in 1 PATCHPATCH, EXTENDED RELEASE311
69238-1662-2Scopolamine10 in 1 CARTONPATCH, EXTENDED RELEASE1011
69238-1662-4Scopolamine3 d in 1 PATCHPATCH, EXTENDED RELEASE311
69238-1662-4Scopolamine24 in 1 CARTONPATCH, EXTENDED RELEASE2411
69238-1662-9Scopolamine4 in 1 CARTONPATCH, EXTENDED RELEASE411
69238-1662-9Scopolamine3 d in 1 PATCHPATCH, EXTENDED RELEASE311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1662-2EA - Each69238-16629634add3-e98d-4067-98b7-18b9a918ab4e12026-02-05
69238-1662-4EA - Each69238-16625454bd10-863b-4dd9-9d42-55d9f6e739b712026-02-05
69238-1662-9EA - Each69238-166206df3951-b5c2-4334-92d5-800d0210ec8912026-02-05

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
ScopolamineSCOPOLAMINEAmneal Pharmaceuticals NY LLC48e6e53a-d904-475b-84dd-6068cc0cb36b2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218384
application number: ANDA218384
ndc (product): 69238-1662

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN48e6e53a-d904-475b-84dd-6068cc0cb36b11
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD48e6e53a-d904-475b-84dd-6068cc0cb36b11
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY48e6e53a-d904-475b-84dd-6068cc0cb36b11
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY48e6e53a-d904-475b-84dd-6068cc0cb36b11
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY48e6e53a-d904-475b-84dd-6068cc0cb36b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-1662-26923816620210 PATCH in 1 CARTON (69238-1662-2) / 3 d in 1 PATCH10 patch2025-06-11NoNoCurrent
69238-1662-46923816620424 PATCH in 1 CARTON (69238-1662-4) / 3 d in 1 PATCH24 patch2025-06-11NoNoCurrent
69238-1662-9692381662094 PATCH in 1 CARTON (69238-1662-9) / 3 d in 1 PATCH4 patch2025-06-11NoNoCurrent