FDA.reportPublic FDA data

NDC 68084-389-11 - 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
68084-389
Requested NDC
68084-389-11
Package NDCs from labels
68084-389-11, 68084-389-01
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
68084-389-01Benztropine Mesylate100 in 1 BOX, UNIT-DOSETABLET10013
68084-389-11Benztropine Mesylate1 in 1 BLISTER PACKTABLET113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-389BENZTROPINE 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
68084-389-01EA - Each68084-3896a7b23c6-09d6-4569-bc89-522f4d53dbe412012-07-24
68084-389-11EA - Each68084-38971d18107-c377-4314-9c18-b0017a47110112012-07-24

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 1 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATEUnit Dose Solutions, Inc.53c02a89-012c-e724-e063-6294a90acc752026-08-17Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885213
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.241479dd-91bf-455a-80a1-1bb2d1c8156d2026-07-28Warnings, Adverse reactionsExact identifier
rxcui: 885219
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.01688e6f-7b22-41bf-9a85-1c88d90f99b62026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEREMEDYREPACK INC.09e3e099-0b29-4ab5-bf35-5e41355dd4542026-06-23Warnings, Adverse reactionsExact identifier
application number: ANDA040742
rxcui: 885213
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC52bd605a-6a28-c2ec-e063-6294a90a83712026-05-26Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885209
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC513b1f4c-d253-6ad7-e063-6394a90a1dab2026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC512ada3e-4b85-d989-e063-6394a90a9d542026-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885219
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC50c61b1d-49d6-37f2-e063-6294a90a05902026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 885219
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC5035534e-e15c-8f06-e063-6294a90a50032026-04-24Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885213
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsbac9dfb7-aa09-4841-9e8f-cc41bb438fe22026-04-15Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885209
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.7430b584-2812-4af5-994a-33dd1afed4762026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATENavinta LLCf92fbafa-314d-4449-831f-26108339e6b22026-03-17Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEDIRECT RX9b93035b-34d6-4084-ba73-5dea72f9d1242026-03-17Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885209
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepackae749a71-d253-474d-a26c-bec780c5b09c2026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 885219
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsdf0647b8-2aa7-4aa4-9ba3-82c28698e7c52026-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885213
rxcui: 885219
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEScieGen Pharmaceuticals Inc1ead16a7-88ed-407d-b25a-0d9a1d9da5ef2026-01-09Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: L11K75P92J
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: L11K75P92J
Rib Cage Pain Drops 2056RIB CAGE PAIN DROPSProfessional Complementary Health Formulasf8051769-9714-4444-b736-04b95af64a9b2026-01-08WarningsExact identifier
unii: L11K75P92J
Seventh Chakra (Crown) 7307SEVENTH CHAKRA (CROWN)Professional Complementary Health Formulas06a2e818-ce9a-4930-adef-5b9990f1b8a32026-01-08WarningsExact identifier
unii: L11K75P92J

Reported adverse events (FAERS/openFDA)#

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