FDA.reportPublic FDA data

NDC 70518-0132-3 - 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
70518-0132
Requested NDC
70518-0132-3
Package NDCs from labels
70518-0132-0, 70518-0132-1, 70518-0132-3, 70518-0132-2
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-23
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.2026-06-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0132-0Benztropine Mesylate30 in 1 BLISTER PACKTABLET3014
70518-0132-1Benztropine Mesylate30 in 1 BLISTER PACKTABLET3014
70518-0132-2Benztropine Mesylate100 in 1 BOXTABLET10014
70518-0132-3Benztropine Mesylate1 in 1 POUCHTABLET114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0132BENZTROPINE MESYLATE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20250529_09e3e099-0b29-4ab5-bf35-5e41355dd454.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 2 · 39 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
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
ndc (package): 70518-0132-1
ndc (package): 70518-0132-2
ndc (package): 70518-0132-0
ndc (package): 70518-0132-3
ndc (product): 70518-0132
ndc11 (package): 70518013203
rxcui: 885213
spl id: 54ee6164-268a-a07d-e063-6294a90a24f5
spl set id: 09e3e099-0b29-4ab5-bf35-5e41355dd454
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC52bd605a-6a28-c2ec-e063-6294a90a83712026-05-26Warnings, Adverse reactionsExact identifier
application number: ANDA040715
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC513b1f4c-d253-6ad7-e063-6394a90a1dab2026-05-07Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC512ada3e-4b85-d989-e063-6394a90a9d542026-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA040715
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC50c61b1d-49d6-37f2-e063-6294a90a05902026-05-01Warnings, Adverse reactionsExact identifier
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
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.7430b584-2812-4af5-994a-33dd1afed4762026-03-24Warnings, Adverse reactionsExact identifier
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
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepackae749a71-d253-474d-a26c-bec780c5b09c2026-02-16Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: O7TSZ97GEP
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsdf0647b8-2aa7-4aa4-9ba3-82c28698e7c52026-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA040715
rxcui: 885213
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEScieGen Pharmaceuticals Inc1ead16a7-88ed-407d-b25a-0d9a1d9da5ef2026-01-09Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack9270d14c-b885-4679-8871-6f25474503982026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510

Reported adverse events (FAERS/openFDA)#

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