FDA.reportPublic FDA data

NDC 72162-2595-01 - 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
72162-2595
Requested NDC
72162-2595-01
Package NDCs from labels
72162-2595-0, 72162-2595-1, 72162-2595-2, 72162-2595-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-01-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BENZTROPINE MESYLATE - Bryant Ranch PrepackBryant Ranch Prepack2026-01-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2595-0BENZTROPINE MESYLATE1000 in 1 BOTTLETABLET1000100
72162-2595-1BENZTROPINE MESYLATE100 in 1 BOTTLETABLET100100
72162-2595-2BENZTROPINE MESYLATE100 in 1 BOTTLE, PLASTICTABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2595-0EA - Each72162-25956942aa6d-4027-41e8-b6b3-030cef44fb9512026-02-05
72162-2595-1EA - Each72162-2595018d2108-6e80-4853-8814-6e36eb86b78912026-02-05
72162-2595-2EA - Each72162-2595989672cf-29a7-4fce-9ca0-97ffce2e506112026-02-05

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack284e78af-7544-4c4a-8081-74e45501dc762026-01-07Warnings, Adverse reactionsExact identifier
application number: ANDA212694
rxcui: 885209
unii: WMJ8TL7510
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Benztropine MesylateBENZTROPINE MESYLATEChartwell RX, LLC.c002005d-a478-48d4-b345-cb87edcb061f2025-12-09Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEAmerican Health Packagingb7f915a9-cd53-4a74-8ee5-35ee5c5c991e2025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEQUAGEN PHARMACEUTICALS LLCe1f0a249-e660-4592-9ffc-1c02b10227782025-06-17Warnings, Adverse reactionsExact identifier
application number: ANDA212694
ndc (product): 70752-124
rxcui: 885213
rxcui: 885209
rxcui: 885219
spl id: 073409b4-0ae6-43d5-804a-a15ca581ecd9
spl set id: e1f0a249-e660-4592-9ffc-1c02b1022778
unii: WMJ8TL7510
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
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEAphena Pharma Solutions - Tennessee, LLCf82c6455-f36b-49d7-881e-6601d513d8462021-01-21Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510
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.