FDA.reportPublic FDA data

NDC 68071-3994-04 - Scopolamine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-3994
Requested NDC
68071-3994-04
Package NDCs from labels
68071-3994-4, 68071-3994-04
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2026-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Scopolamine - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2026-05-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3994-4Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE11
68071-3994-4Scopolamine4 in 1 CARTONPATCH, EXTENDED RELEASE41

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ScopolamineSCOPOLAMINEIngenus Pharmaceuticals, LLC2a6f9aaf-a70a-481f-a82b-1dcaaadc185b2026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA212342
ndc (product): 50742-505
rxcui: 226552
spl id: 3baa2417-8daa-4253-89a4-fef4be344fc1
spl set id: 2a6f9aaf-a70a-481f-a82b-1dcaaadc185b
unii: DL48G20X8X
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: 4XYU5U00C4
ScopolamineSCOPOLAMINERhodes Pharmaceuticals LLCba5a1237-4d23-441a-808e-96b97045fbe22026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
ScopolamineSCOPOLAMINENuCare Pharmaceuticals, Inc.51289d8b-f7e3-a3e0-e063-6294a90add432026-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA212342
ndc (package): 68071-3994-4
ndc (product): 68071-3994
ndc11 (package): 68071399404
rxcui: 226552
spl id: 51288b87-a0ea-5505-e063-6394a90a3736
spl set id: 51289d8b-f7e3-a3e0-e063-6294a90add43
unii: DL48G20X8X
ScopolamineSCOPOLAMINEBryant Ranch Prepack5aa64f85-ae52-4a86-a894-a4e536fbe4ad2026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
ScopolamineSCOPOLAMINEBryant Ranch Prepackdd031a59-6b8c-49b1-9b4d-e7a7b75e38012026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
ScopolamineSCOPOLAMINEBryant Ranch Prepack8d53ee59-e0ef-4332-a6d6-0ac5a6c21b552026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
ScopolamineSCOPOLAMINEBryant Ranch Prepacka472ee74-76a7-470f-8564-9018940a82e82026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
ScopolamineSCOPOLAMINEZydus Pharmaceuticals USA Inc.62d8332e-b8d2-4d13-8071-978d57e519282025-08-23Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
ScopolamineSCOPOLAMINEZydus Lifesciences Limited016df9f3-61d5-45e9-b1d6-791a5d2f26d52025-08-23Exact identifier
rxcui: 226552
unii: DL48G20X8X
Scopolamine Transdermal SystemSCOPOLAMINE TRANSDERMAL SYSTEMBryant Ranch Prepack8455ce88-1270-440b-b62e-fe5fef1415ac2025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
ScopolamineSCOPOLAMINEMylan Pharmaceuticals Inc.163accb7-45e6-4d97-844d-72b6066770082025-07-08Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
scopolamineSCOPOLAMINEActavis Pharma, Inc.800b6421-48eb-47f5-b255-c12f75e590682025-06-12Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
Transderm ScopSCOPOLAMINEBaxter Healthcare Corporationb877a694-a1d0-4280-937a-a06820b12a882025-06-10Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
Scopolamine Transdermal SystemSCOPOLAMINE TRANSDERMAL SYSTEMPadagis Israel Pharmaceuticals Ltdcb93bfad-3e37-4a27-92f6-f21703ae7bdf2025-05-31Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
ScopolamineSCOPOLAMINEAmneal Pharmaceuticals NY LLC48e6e53a-d904-475b-84dd-6068cc0cb36b2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 76845O8NMZ
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: E1NC1JVS3O
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: E1NC1JVS3O
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 76845O8NMZ

Reported adverse events (FAERS/openFDA)#

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