FDA.reportPublic FDA data

NDC 0517-0785-01 - Benztropine Mesylate

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
0517-0785
Requested NDC
0517-0785-01
Package NDCs from labels
0517-0785-01, 0517-0785-05
Manufacturer
American Regent, Inc.
Effective date
2011-05-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benztropine Mesylate Injection, USPAmerican Regent, Inc.2011-05-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0517-0785-052019-12-04C16284748780-1960f7f55-d8ad-8e05-e053-dbdaa90a074aBenztropine Mesylate Injection, USP
0517-0785-052019-10-29C16284748780-1960f7f55-d8ad-8e05-e053-dbdaa90a074aBenztropine Mesylate Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0785-05ML - Milliliter0517-07853378fb4c-9f3a-42a7-b1b0-ef6803f5355312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBENZTROPINE MESYLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1

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 6 of 53 · 1,050 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC513b1f4c-d253-6ad7-e063-6394a90a1dab2026-05-07Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC512ada3e-4b85-d989-e063-6394a90a9d542026-05-06Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC50c61b1d-49d6-37f2-e063-6294a90a05902026-05-01Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC5035534e-e15c-8f06-e063-6294a90a50032026-04-24Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsbac9dfb7-aa09-4841-9e8f-cc41bb438fe22026-04-15Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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