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Active ingredient

Scopolamine

21 finished FDA listings contain Scopolamine as their only active ingredient; 12 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
SCOPOLAMINE, SCOPOLAMINE HYDROBROMIDE
Dosage forms
Patch, Patch, Extended Release, System
Routes
Transdermal
Manufacturers / labelers
12
Strengths listed
1 mg/1 · 1 mg/3d · 1.5 mg/1
Brand names in FDA listings
Scopolamine Trandermal System, Transderm Scop

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 9601

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 017874BAXTER HLTHCARE CORP1979-12-311
ANDA 078830PADAGIS US2015-01-306
ANDA 203753MYLAN TECHNOLOGIES2019-06-192
ANDA 212342RICONPHARMA LLC2020-11-242
ANDA 208769ACTAVIS LABS UT INC2022-01-102
ANDA 215329RHODES PHARMS2024-05-065
ANDA 217893ZYDUS PHARMS2024-08-292
ANDA 218384AMNEAL2025-06-091

Official labeling on DailyMed

Showing the 12 most recent of 21 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.