Benztropine Mesylate

Product NDC
68084-381
11-digit product format
680840381
Labeler code
68084
Product ID
68084-381_43e32855-d7c9-07e1-e063-6294a90af347
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040715
Marketing category
ANDA
Marketing start
2009-11-09
Substance
BENZTROPINE MESYLATE
Active strength
.5 mg/1
Pharmacologic classes
Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benztropine Mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZTROPINE MESYLATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWMJ8TL7510
Rxcui885209, 885213, 885219

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2961cf47-535c-c402-c24d-0a9130269674Product name320251121
3f930a8b-cc65-fba9-e4ca-58b6abcea16bProduct name220220509

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSNb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885213benztropine mesylate 1 MG Oral TabletPSNb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885209benztropine mesylate 2 MG Oral TabletPSNb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885219benztropine mesylate 0.5 MG Oral TabletSCDb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885213benztropine mesylate 1 MG Oral TabletSCDb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13
885209benztropine mesylate 2 MG Oral TabletSCDb7f915a9-cd53-4a74-8ee5-35ee5c5c991e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68084-381-0168084038101100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-381-01) / 1 TABLET in 1 BLISTER PACK (68084-381-11) 100 blister pack2009-11-09NoNoCurrent
68084-381-11680840381111 in 1 BLISTER PACKHistorical