FDA.reportPublic FDA data

NDC 70518-0577-4 - 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
70518-0577
Requested NDC
70518-0577-4
Package NDCs from labels
70518-0577-0, 70518-0577-1, 70518-0577-2, 70518-0577-4, 70518-0577-3, 70518-0577-6, 70518-0577-5
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mgREMEDYREPACK INC.2026-06-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0577-0BENZTROPINE MESYLATE30 in 1 BLISTER PACKTABLET3025
70518-0577-1BENZTROPINE MESYLATE28 in 1 BLISTER PACKTABLET2825
70518-0577-2BENZTROPINE MESYLATE30 in 1 BLISTER PACKTABLET3025
70518-0577-3BENZTROPINE MESYLATE100 in 1 BOXTABLET10025
70518-0577-4BENZTROPINE MESYLATE1 in 1 POUCHTABLET125
70518-0577-5BENZTROPINE MESYLATE100 in 1 BOXTABLET10025
70518-0577-6BENZTROPINE MESYLATE1 in 1 POUCHTABLET125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0577BENZTROPINE MESYLATE TABLET [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 7 package rows20250429_01688e6f-7b22-41bf-9a85-1c88d90f99b6.zip

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 4 · 64 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
rxcui: 885213
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.241479dd-91bf-455a-80a1-1bb2d1c8156d2026-07-28Warnings, Adverse reactionsExact identifier
application number: ANDA090168
rxcui: 885219
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.01688e6f-7b22-41bf-9a85-1c88d90f99b62026-06-29Warnings, Adverse reactionsExact identifier
application number: ANDA090168
ndc (package): 70518-0577-2
ndc (package): 70518-0577-1
ndc (package): 70518-0577-5
ndc (package): 70518-0577-0
ndc (package): 70518-0577-4
ndc (package): 70518-0577-3
ndc (package): 70518-0577-6
ndc (product): 70518-0577
ndc11 (package): 70518057704
rxcui: 885213
spl id: 5563ab2e-709a-1c8f-e063-6294a90a8503
spl set id: 01688e6f-7b22-41bf-9a85-1c88d90f99b6
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEREMEDYREPACK INC.09e3e099-0b29-4ab5-bf35-5e41355dd4542026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC52bd605a-6a28-c2ec-e063-6294a90a83712026-05-26Warnings, Adverse reactionsExact identifier
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
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
rxcui: 885213
unii: WMJ8TL7510
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsbac9dfb7-aa09-4841-9e8f-cc41bb438fe22026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.7430b584-2812-4af5-994a-33dd1afed4762026-03-24Warnings, Adverse reactionsExact identifier
application number: ANDA090168
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
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
rxcui: 885213
rxcui: 885219
unii: WMJ8TL7510
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
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

Reported adverse events (FAERS/openFDA)#

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