FDA.reportPublic FDA data

NDC 68084-381-11 - 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
68084-381
Requested NDC
68084-381-11
Package NDCs from labels
68084-381-11, 68084-381-01
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
68084-381-01Benztropine Mesylate100 in 1 BOX, UNIT-DOSETABLET10013
68084-381-11Benztropine Mesylate1 in 1 BLISTER PACKTABLET113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-381BENZTROPINE 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
68084-381-01EA - Each68084-381f705a645-1c95-4d07-ae39-8fa235ada9c912012-07-24
68084-381-11EA - Each68084-3816f5a900e-30c7-47e6-9286-5c42975f3df812012-07-24

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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memory Drops 2043MEMORY DROPSProfessional Complementary Health Formulasa9b8897b-e5a1-4db3-94dd-8012aded6ed72026-01-08WarningsExact identifier
unii: L11K75P92J
Calcarea Phosphorica 8002CALCAREA PHOSPHORICAProfessional Complementary Health Formulas555dd940-ed07-4160-bae3-1b4d320dec662026-01-08WarningsExact identifier
unii: L11K75P92J
Calcarea Combination 9214CALCAREA COMBINATIONProfessional Complementary Health Formulas54b605d6-1e58-41b1-865b-1280ed75d4942026-01-08WarningsExact identifier
unii: L11K75P92J
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: L11K75P92J
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: L11K75P92J
Lactation Flow Drops 2149LACTATION FLOW DROPSProfessional Complementary Health Formulas66a063c4-aa38-4c8e-b361-ee841165edeb2026-01-08WarningsExact identifier
unii: L11K75P92J
Nocturnal Enuresis Drops 2011NOCTURNAL ENURESIS DROPSProfessional Complementary Health Formulas9cd29086-c9eb-4db1-a219-2a8bae3663d82026-01-08WarningsExact identifier
unii: L11K75P92J
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: L11K75P92J
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: L11K75P92J
Myosotis Combination 9234MYOSOTIS COMBINATIONProfessional Complementary Health Formulas8cc292dc-b959-4d81-8277-03044992fccb2026-01-08WarningsExact identifier
unii: L11K75P92J
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: L11K75P92J
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: L11K75P92J
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: L11K75P92J
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack9270d14c-b885-4679-8871-6f25474503982026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack284e78af-7544-4c4a-8081-74e45501dc762026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
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
application number: ANDA040715
ndc (package): 68084-388-11
ndc (package): 68084-381-11
ndc (package): 68084-389-11
ndc (package): 68084-381-01
ndc (package): 68084-389-01
ndc (package): 68084-388-01
ndc (product): 68084-388
ndc (product): 68084-389
ndc (product): 68084-381
ndc11 (package): 68084038111
rxcui: 885213
rxcui: 885209
rxcui: 885219
spl id: 43e32855-d7c9-07e1-e063-6294a90af347
spl set id: b7f915a9-cd53-4a74-8ee5-35ee5c5c991e
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
BENZTROPINE MESYLATEBENZTROPINE MESYLATEQUAGEN PHARMACEUTICALS LLCe1f0a249-e660-4592-9ffc-1c02b10227782025-06-17Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885209
rxcui: 885219
unii: WMJ8TL7510

Reported adverse events (FAERS/openFDA)#

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