BENZTROPINE MESYLATE

Product NDC
72162-2594
11-digit product format
721622594
Labeler code
72162
Product ID
72162-2594_09e681e1-2cb0-4d77-923e-83890f9161ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212694
Marketing category
ANDA
Marketing start
2025-08-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BENZTROPINE MESYLATE
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWMJ8TL7510
Rxcui885219

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
72162-2594-0BENZTROPINE MESYLATE1000 in 1 BOTTLETABLET1000101
72162-2594-1BENZTROPINE MESYLATE100 in 1 BOTTLETABLET100101
72162-2594-2BENZTROPINE MESYLATE100 in 1 BOTTLETABLET100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2594-0EA - Each72162-2594d0532c3a-e1a3-4979-ac14-cb238113c63812026-02-05
72162-2594-1EA - Each72162-25949aa2f922-2563-4b30-b33b-1f94365f18b712026-02-05
72162-2594-2EA - Each72162-25948f9507ad-f294-4d85-8898-7c8bc5f06c9b12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885219benztropine mesylate 0.5 MG Oral TabletPSNae749a71-d253-474d-a26c-bec780c5b09c101
885219benztropine mesylate 0.5 MG Oral TabletSCDae749a71-d253-474d-a26c-bec780c5b09c101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2594-0721622594001000 TABLET in 1 BOTTLE (72162-2594-0) 1000 tablet2026-01-07NoNoHistorical
72162-2594-172162259401100 TABLET in 1 BOTTLE (72162-2594-1) 100 tablet2026-01-07NoNoHistorical
72162-2594-272162259402100 TABLET in 1 BOTTLE (72162-2594-2) 100 tablet2026-01-07NoNoHistorical