FDA.reportPublic FDA data

NDC 70518-2732-3 - 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
70518-2732
Requested NDC
70518-2732-3
Package NDCs from labels
70518-2732-0, 70518-2732-1, 70518-2732-2, 70518-2732-3, 70518-2732-4, 70518-2732-6, 70518-2732-5
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-28
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.2026-07-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2732-0BENZTROPINE MESYLATE30 in 1 BLISTER PACKTABLET3014
70518-2732-1BENZTROPINE MESYLATE28 in 1 BLISTER PACKTABLET2814
70518-2732-2BENZTROPINE MESYLATE60 in 1 BLISTER PACKTABLET6014
70518-2732-3BENZTROPINE MESYLATE1 in 1 POUCHTABLET114
70518-2732-4BENZTROPINE MESYLATE100 in 1 BOXTABLET10014
70518-2732-5BENZTROPINE MESYLATE100 in 1 BOXTABLET10014
70518-2732-6BENZTROPINE MESYLATE1 in 1 POUCHTABLET114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2732BENZTROPINE MESYLATE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 7 package rows20250331_241479dd-91bf-455a-80a1-1bb2d1c8156d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2732-0EA - Each70518-27328f38c1fa-4a28-4ae5-9e8e-236e0b5ff93512024-04-05

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATEAmerican Health Packagingb7f915a9-cd53-4a74-8ee5-35ee5c5c991e2025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltdc277f1d8-2ee0-4111-adb6-38998f77dede2025-07-18WarningsExact identifier
unii: L11K75P92J
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltd81d59754-1b36-4f71-aec1-5335b003a96f2025-07-01WarningsExact identifier
unii: L11K75P92J
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
BENZTROPINE MESYLATEBENZTROPINE MESYLATEQUAGEN PHARMACEUTICALS LLCe1f0a249-e660-4592-9ffc-1c02b10227782025-06-17Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
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
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
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Benztropine MesylateBENZTROPINE MESYLATEA-S Medication Solutions53b134eb-b341-4fe4-a3ca-90a7da0119742024-01-07Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEBryant Ranch Prepack959363b8-6847-4f6e-9957-6254febb085c2023-05-30Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATELeading Pharma, LLCfe002ec4-07cb-41ca-a58c-33b3a86821012021-11-14Warnings, Adverse reactionsExact identifier
application number: ANDA090168
ndc (product): 69315-136
rxcui: 885213
rxcui: 885209
rxcui: 885219
spl id: f61e0118-7898-42cf-9e27-e5f2dabe6ea4
spl set id: fe002ec4-07cb-41ca-a58c-33b3a8682101
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
application number: ANDA090168
rxcui: 885213
unii: WMJ8TL7510

Reported adverse events (FAERS/openFDA)#

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