FDA.reportPublic FDA data

NDC 63629-8451-2 - Scopolamine Trandermal System

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
63629-8451
Requested NDC
63629-8451-2
Package NDCs from labels
63629-8451-2, 63629-8451-1
Manufacturer
Bryant Ranch Prepack
Effective date
2024-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Scopolamine Trandermal System - Bryant Ranch PrepackBryant Ranch Prepack2024-05-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8451-1Scopolamine Trandermal System10 in 1 CARTONPATCH, EXTENDED RELEASE10107
63629-8451-2Scopolamine Trandermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8451SCOPOLAMINE TRANDERMAL SYSTEM (SCOLOPAMINE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 2 package rows20250316_1099a330-fcb8-4acd-9ef8-525024c6b9d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8451-1EA - Each63629-84513e2c4216-ad63-4bec-9c72-d2f9adea321412021-07-15

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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. , LTD3b329232-a562-6893-e063-6394a90aa41f2025-07-31WarningsExact identifier
unii: N6K5787QVP
Scopolamine Transdermal SystemSCOPOLAMINE TRANSDERMAL SYSTEMBryant Ranch Prepack8455ce88-1270-440b-b62e-fe5fef1415ac2025-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA078830
rxcui: 226552
unii: DL48G20X8X
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMMajor Pharmaceuticals3ab32e69-b8da-f187-e063-6294a90afa9a2025-07-24WarningsExact identifier
unii: N6K5787QVP
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
unii: N6K5787QVP
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
application number: ANDA078830
ndc (product): 45802-580
rxcui: 226552
spl id: d334a21d-7546-477f-a66a-f95b2cf523ce
spl set id: cb93bfad-3e37-4a27-92f6-f21703ae7bdf
unii: DL48G20X8X
ScopolamineSCOPOLAMINEAmneal Pharmaceuticals NY LLC48e6e53a-d904-475b-84dd-6068cc0cb36b2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
unii: N6K5787QVP
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 8CRQ2TH63M
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 8CRQ2TH63M
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: N6K5787QVP
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: N6K5787QVP
scopolamineSCOPOLAMINEA-S Medication Solutions5c232a94-0842-4efc-98a6-9d23e3b15a762024-07-05Warnings, Adverse reactionsExact identifier
rxcui: 226552
unii: DL48G20X8X
Scopolamine Trandermal SystemSCOLOPAMINE TRANSDERMAL SYSTEMBryant Ranch Prepack81c57d46-1617-4295-8a60-acb7e365551c2024-06-05Warnings, Adverse reactionsExact identifier
application number: ANDA078830
rxcui: 226552
unii: DL48G20X8X
Scopolamine Trandermal SystemSCOLOPAMINE TRANSDERMAL SYSTEMBryant Ranch Prepack1099a330-fcb8-4acd-9ef8-525024c6b9d62024-05-30Warnings, Adverse reactionsExact identifier
application number: ANDA078830
ndc (package): 63629-8451-1
ndc (package): 63629-8451-2
ndc (product): 63629-8451
ndc11 (package): 63629845102
rxcui: 226552
spl id: 31757cae-a379-4680-9f6e-404b57071f20
spl set id: 1099a330-fcb8-4acd-9ef8-525024c6b9d6
unii: DL48G20X8X
Scopolamine Trandermal SystemSCOLOPAMINE TRANSDERMAL SYSTEMBryant Ranch Prepackc89cc74e-9506-48e5-bbb7-26b454b498aa2024-05-30Warnings, Adverse reactionsExact identifier
application number: ANDA078830
rxcui: 226552
unii: DL48G20X8X
Scopolamine Trandermal SystemSCOLOPAMINE TRANSDERMAL SYSTEMBryant Ranch Prepack69401d6f-3d18-48b0-b28c-a578c9834f322024-01-05Warnings, Adverse reactionsExact identifier
application number: ANDA078830
rxcui: 226552
unii: DL48G20X8X
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 8CRQ2TH63M

Reported adverse events (FAERS/openFDA)#

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