FDA.reportPublic FDA data

NDC 68084-381-11 - 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
68084-381
Requested NDC
68084-381-11
Package NDCs from labels
68084-381-11, 68084-381-01
Manufacturer
American Health Packaging
Effective date
2025-11-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benztropine Mesylate - American Health PackagingAmerican Health Packaging2025-11-18HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-381-01Benztropine Mesylate100 in 1 BOX, UNIT-DOSETABLET10013
68084-381-11Benztropine Mesylate1 in 1 BLISTER PACKTABLET113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-381BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 2 package rows20241215_b7f915a9-cd53-4a74-8ee5-35ee5c5c991e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-381-01EA - Each68084-381f705a645-1c95-4d07-ae39-8fa235ada9c912012-07-24
68084-381-11EA - Each68084-3816f5a900e-30c7-47e6-9286-5c42975f3df812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZTROPINE MESYLATEACTIVE INGREDIENTWMJ8TL7510BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
BENZTROPINEACTIVE MOIETY1NHL2J4X8KBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]4

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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZTROPINE MESYLATEBENZTROPINE MESYLATEMarlex PHARMACEUTICAL, INC31bbcbfa-dc74-99e2-e063-6394a90aa6082025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Benztropine MesylateBENZTROPINE MESYLATEMajor Pharmaceuticals8b18b66c-2935-4304-8e20-ebf68dee5a1a2025-01-16Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEZydus Pharmaceuticals USA Inc.ecaeaadf-0847-4605-a205-a674f75f8bb22024-12-20Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATESUNRISE PHARMACEUTICAL, INC2c988462-ce77-4e99-b98e-8f6ad519e2952024-10-16Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEFresenius Kabi USA, LLCb03bd28e-3b44-41e4-9a7e-28b9d79752452024-10-11Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEHikma Pharmaceuticals USA Inc.accd7e33-ca6e-46e6-a2ae-20b9bcd8fb892024-04-11Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEHikma Pharmaceuticals USA Inc.95620f40-5ddf-41b8-80a5-f658248f26f02024-04-11Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEA-S Medication Solutions53b134eb-b341-4fe4-a3ca-90a7da0119742024-01-07Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885213
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEBryant Ranch Prepack959363b8-6847-4f6e-9957-6254febb085c2023-05-30Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885209
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATELeading Pharma, LLCfe002ec4-07cb-41ca-a58c-33b3a86821012021-11-14Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: L11K75P92J
BENZTROPINE MESYLATEBENZTROPINE MESYLATEAphena Pharma Solutions - Tennessee, LLCf82c6455-f36b-49d7-881e-6601d513d8462021-01-21Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510
MEDULLOSSEINUM PLEXARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALESeroyal USA22b7eafe-ef76-0677-e054-00144ff88e882020-10-09WarningsExact identifier
unii: L11K75P92J
Benztropine MesylateBENZTROPINECipla USA Inc.3d2732f9-b8a9-4e83-91e7-da616ddcb7862020-05-01Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEProficient Rx LPc1044563-2bd2-4f43-a951-25d083b1c6792019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510

Reported adverse events (FAERS/openFDA)#

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